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Study Design. Retrospective cohort study. Objective. To investigate the impact of age on the incidence of vascular complications in patients undergoing anterior lumbar approach surgery. Background. Anterior approach lumbar spinal surgery may facilitate the use of intervertebral devices with larger endplate coverage and increased lordosis. Despite the advantages of this approach, risks related to vascular injury in older patients have been described in the literature. Patients and Methods. In total, 751 consecutive patients with degenerative spinal pathology who underwent stand-alone anterior lumbar interbody fusion (ALIF), ALIF combined with posterior fusion and/or instrumentation (360), total disc replacement, or hybrid procedures (ALIF and total disc replacement) were included. Data collected included general patient descriptive data, surgery details, intraoperative vascular injury, and postoperative vascular complications (deep vein thrombosis and/or pulmonary embolism). Rates of vascular complications were compared across age groups. In addition, the mean age of patients was compared between those with versus without vascular complications. Results. Overall mean age was 50.4 years (range: 20--83 yr). The mean estimated blood loss was 91.3 mL (range: 10--2800 mL). A total of 15 patients, 2.0%, had vascular complications. There were 10 cases (1.3%) of intraoperative injury to iliac arteries or iliolumbar veins (mean blood loss was 721 mL, and all were repaired intraoperatively). Postoperatively, 6 patients (0.8%) developed deep vein thrombosis and/or pulmonary embolism (one patient had both). With respect to age, there were no significant differences in rates of intraoperative, postoperative, or combined vascular complication rates across the age group (P > 0.38). In addition, there were no statistically significant differences in the mean ages of patients with versus those without vascular complications (P > 0.17). Conclusion. Overall incidence of vascular complications was 2.0%. No relationship between vascular complications and age was demonstrated. These data suggest that increased age may not necessarily be an absolute contraindication for anterior lumbar approach surgery. [ABSTRACT FROM AUTHOR]

Study Design. Retrospective cohort study. Background. Cervical TDR has gained acceptance as an alternative to anterior cervical discectomy and fusion in appropriately selected patients. There have been concerns over device safety, one measure of which is subsequent surgery related to device problems. Patients and Methods. A consecutive series of 1626 patients undergoing cervical TDR from 2003 to June 2021 were included, consisting of TDRs up to 3 levels and hybrids (TDR and fusion). TDR removal or revision surgeries and reasons for these surgeries, procedures performed, and duration from index procedure were recorded. Data were analyzed to determine the removal/revision rate and factors possibly related to these events. Results. There were 24 removals/revisions (1.48%) in the 1626 patients. Removal was performed in 23 cases (1.41%) and revision in 1 (0.06%). Among removal cases, anterior cervical discectomy and fusion was performed in 18 and TDR was replaced with another TDR in 5. Removals with fusion included 5 cases of osteolysis with/without Cutibacterium acnes, 4 device displacement/migration, 4 posterior spinal pathology, and one for each of the following: metal allergy, approach-related complications, malpositioning, subsidence, and hypermobility. The revision involved TDR repositioning 3 days after index surgery. There were 66 patients for whom a minimum of 10-year followup was confirmed, and none had removal/revision surgery 10 or more years after index surgery. There was no relationship between the occurrence of removal/revision and age, sex, body mass index, or physician experience (learning curve). The removal/revision rate was significantly higher in FDA trials versus postapproval (4.1% vs. 1.3%, P < 0.05). Conclusion. In this large consecutive series of patients, 1.48% of cervical TDRs were removed/revised. The low rate of removals/revisions over a long period of time provides support for the devices' safety. [ABSTRACT FROM AUTHOR]

Purpose: To analyze of the results of spine surgical treatment of athletes with lumbar degenerative disease and development of a surgical strategy based on the preoperative symptoms and radiological changes in the lumbar spine. Methods: For 114 athletes with lumbar degenerative disease were included in the present study. Four independent groups were studied: (1) microsurgical/endoscopic discectomy (n = 35); (2) PRP therapy in facet joints (n = 41); (3) total disc replacement (n = 11); (4) lumbar interbody fusion (n = 27). We evaluated postoperative clinical outcomes and preoperative radiological results. The average postoperative follow-up was 5 (3;6), 3.5 (3;5), 3 (2;4) and 4 (3;5) years, respectively. The analysis included an assessment of clinical outcomes (initial clinical symptoms, chronic pain syndrome level according to the VAS, quality of life according to the SF-36 questionnaire, degree of tolerance to physical activity according to the subjective Borg Rating of Perceived Exertion Scale) and radiological data (Dynamic Slip, Dynamic Segmental Angle, degenerative changes in the facet joint according to the Fujiwara classification and disc according to the Pfirrmann classification; changes in the diffusion coefficient using diffusion-weighted MRI). Results: The median and 25–75% quartiles timing of return to sports were 12.6 (10.2;14.1), 2.8 (2.4;3.7), 9 (6;12), and 14 (9;17) weeks, respectively. We examined the type of surgical treatment utilized, as well as the preoperative clinical symptoms, severity of degenerative changes in the intervertebral disc and facet joint, the timing of return to sports, the level of pain syndrome, the quality of life according to SF-36, and the degree of tolerance to physical activity. We then developed a surgical strategy based on individual preoperative neurological function and lumbar morphological changes. Conclusions: In this retrospective study, we report clinical results of four treatment options of lumbar spine degenerative disease in athletes. The use of developed patient selection criteria for the analyzed surgical techniques is aimed at minimizing return-to-play times. [ABSTRACT FROM AUTHOR]

Background: Mechanical augmentation upon implantation is essential for the long‐term success of tissue‐engineered intervertebral discs (TE‐IVDs). Previous studies utilized stiffer materials to fabricate TE‐IVD support structures. However, these materials undergo various failure modes in the mechanically challenging IVD microenvironment. FlexiFil (FPLA) is an elastomeric 3D printing filament that is amenable to the fabrication of support structures. However, no present study has evaluated the efficacy of a flexible support material to preserve disc height and support the formation of hydrated tissues in a large animal model. Methods: We leveraged results from our previously developed FE model of the minipig spine to design and test TE‐IVD support cages comprised of FPLA and PLA. Specifically, we performed indentation to assess implant mechanical response and scanning electron microscopy to visualize microscale damage. We then implanted FPLA and PLA support cages for 6 weeks in the minipig cervical spine and monitored disc height via weekly x‐rays. TE‐IVDs cultured in FPLA were also implanted for 6 weeks with weekly x‐rays and terminal T2 MRIs to quantify tissue hydration at study endpoint. Results: Results demonstrated that FPLA cages withstood nearly twice the deformation of PLA without detrimental changes in mechanical performance and minimal damage. In vivo, FPLA cages and stably implanted TE‐IVDs restored native disc height and supported the formation of hydrated tissues in the minipig spine. Displaced TE‐IVDs yielded disc heights that were superior to PLA or discectomy‐treated levels. Conclusions: FPLA holds great promise as a flexible and bioresorbable material for enhancing the long‐term success of TE‐IVD implants. [ABSTRACT FROM AUTHOR]

Purpose: To describe modes of failure of cervical TDR, their related treatment strategies, and to describe a management strategy for the treatment of failed cervical TDR. Methods: This retrospective study was based on a consecutive series of 53 cervical TDR patients who underwent removal or revision surgery. Chart review was conducted to collect general descriptive data, reasons for TDR removal/revision, duration from index implantation to re-operation, and the subsequent procedure performed. Results: Among 53 patients, 36 underwent TDR removal and fusion, 16 underwent TDR removal and replacement with another TDR, and one patient's TDR was revised by repositioning. The mean duration from index surgery to removal/revision was 40.1 months (range: 3 days–222 months). In all cases, removal/revision surgery was completed without complication. The most common reason for removal was severe osteolysis, often involving C. acnes infection, and was primarily associated with one implant type. TDR removal and fusion were performed for subsidence, device migration, treatment of symptoms arising from posterior anatomy (facet joints, etc.), approach-related complications and pain. TDR replacement was feasible for hypermobility, metal allergy, implant locked in kyphosis, and oversized implant use. In one case of TDR malpositioning, the device was successfully revised into appropriate position. Conclusion: After cervical TDR failure, replacing a TDR with another implant can be feasible. Reasons for revision or removal after cervical TDR surgery include biomechanical failure, implant migration, surgeon or technical error, or biological reasons. The type of failure can help the surgeon create a strategy to address these complications. [ABSTRACT FROM AUTHOR]

The motion limitation after cervical discectomy and fusion alters the spine´s kinematics. Unphysiological strains may be the result and possible explanation for adjacent segment degeneration. Alterations to cervical kinematics due to cervical total disc replacement (TDR), especially two-level, are still under investigated. To investigate cervical motion including coupled motions after one-level and two-level TDR in the treated and also the adjacent segments. An in-vitro study using pure moment loading of human donor spines. Seven fresh frozen human cervical spine specimens (C4–T1, median age 46 with range 19–60 years, four female) were included in this study. Specimens were tested in the intact condition first, followed by one-level TDR at C5–6 which was subsequently extended one level further caudal (C5–7). Each specimen was quasistatically loaded with pure moments up to 1.5 Nm in flexion/extension (FE), lateral bending (LB), and axial rotation (AR) in a universal spine tester for 3.5 cycles at 1 °/s. During the tests three dimensional motion tracking was performed for each vertebral body individually. From that, the primary and coupled ROM of each spinal level during the third full cycle of motion were evaluated. Nonparametric statistical analysis was performed using a Friedman-test and post hoc correction with Dunn-Bonferroni-tests (p<.05). Ethics approval was obtained in advance. In FE, one-level TDR (C5–6) moderately increased primary FE in all four segments, but only significantly at the cranial adjacent level C4–5. Additional TDR at C6–7 further increased the ROM at the target segment without much influence on the other levels. Increasing implant height at C6–7 partially counteracted the increased FE. Coupled motions were minimal in all test conditions at all levels. In LB, coupled AR was observed in all test conditions at all levels. One-level TDR decreased primary LB at the target segment C5–6 significantly, without much influence on the other levels. Extending TDR to C6–7 decreased ROM in the target segment but without gaining statistical significance. Increasing implant height at C6–7 further decreased primary LB at the target segment, still without significance. Notably, coupled AR was significantly decreased at the cranial adjacent segment C4–5 compared to the intact condition. In AR, coupled LB was observed in all test conditions at the levels C4–5, C5–6, and C6–7, while the transition level to the thoracic spine C7–T1 showed only little coupled LB. Both one-level and two-level TDR showed little influence on primary AR or coupled motions at any level. Only after increasing implant height at C6–7 was the motion of the caudally adjacent level C7–T1 significantly altered. Evaluating primary FE, LB, and AR together with the associated coupled motions revealed widespread influence of cervical TDR not only on the motion of the treated level but also at the adjacent segments. The influence of two-level TDR is more widespread and involves more levels than one-level TDR. The prevention of unphysiological strains due to altered kinematics after cervical fusion, which could possibly explain adjacent segment degeneration, were a driving factor in the development of TDR. These experimental findings suggest cervical TDR influences the whole cervical spine, not only the treated segment. The effect becomes more extensive, involving more levels and motion directions, after two-level than after one-level TDR. [ABSTRACT FROM AUTHOR]

Study Design: Systematic Review. Objectives: To systematically review the clinical outcomes, re-operation, and complication rates of lumbar TDR devices at mid-to long-term follow-up studies for the treatment of lumbar degenerative disc disease (DDD). Methods: A systematic search was conducted on PubMed, SCOPUS, and Google Scholar to identify follow-up studies that evaluated clinical outcomes of lumbar TDR in patients with DDD. The included studies met the following criteria: prospective or retrospective studies published from 2012 to 2022; a minimum of 5 years post-operative follow-up; a study sample size >10 patients; patients >18 years of age; containing clinical outcomes with Oswestry Disability Index (ODI), Visual Analog Scale (VAS), complication or reoperation rates. Results: Twenty-two studies were included with data on 2284 patients. The mean follow-up time was 8.30 years, with a mean follow-up rate of 86.91%. The study population was 54.97% female, with a mean age of 42.34 years. The mean VAS and ODI pain score improvements were 50.71 ± 6.91 and 30.39 ± 5.32 respectively. The mean clinical success and patient satisfaction rates were 74.79% ± 7.55% and 86.34% ± 5.64%, respectively. The mean complication and reoperation rates were 18.53% ± 6.33% and 13.6% ± 3.83%, respectively. There was no significant difference when comparing mid-term and long-term follow-up studies for all clinical outcomes. Conclusions: There were significant improvements in pain reduction at last follow-up in patients with TDRs. Mid-term follow-up data on clinical outcomes, complication and reoperation rates of lumbar TDRs were maintained longer term. [ABSTRACT FROM AUTHOR]

Abstract Background Mechanical augmentation upon implantation is essential for the long‐term success of tissue‐engineered intervertebral discs (TE‐IVDs). Previous studies utilized stiffer materials to fabricate TE‐IVD support structures. However, these materials undergo various failure modes in the mechanically challenging IVD microenvironment. FlexiFil (FPLA) is an elastomeric 3D printing filament that is amenable to the fabrication of support structures. However, no present study has evaluated the efficacy of a flexible support material to preserve disc height and support the formation of hydrated tissues in a large animal model. Methods We leveraged results from our previously developed FE model of the minipig spine to design and test TE‐IVD support cages comprised of FPLA and PLA. Specifically, we performed indentation to assess implant mechanical response and scanning electron microscopy to visualize microscale damage. We then implanted FPLA and PLA support cages for 6 weeks in the minipig cervical spine and monitored disc height via weekly x‐rays. TE‐IVDs cultured in FPLA were also implanted for 6 weeks with weekly x‐rays and terminal T2 MRIs to quantify tissue hydration at study endpoint. Results Results demonstrated that FPLA cages withstood nearly twice the deformation of PLA without detrimental changes in mechanical performance and minimal damage. In vivo, FPLA cages and stably implanted TE‐IVDs restored native disc height and supported the formation of hydrated tissues in the minipig spine. Displaced TE‐IVDs yielded disc heights that were superior to PLA or discectomy‐treated levels. Conclusions FPLA holds great promise as a flexible and bioresorbable material for enhancing the long‐term success of TE‐IVD implants.

Cervical total disc replacement (TDR) aims to maintain normal cervical kinematics after surgery. This study investigates the relation between shifted location of centre of rotation (COR) and subsequent surgical outcomes after multilevel cervical TDR (MCTDR) and identifies radiological parameter that corresponded to this change of COR after MCTDR. The study included a consecutive 24 patients treated with MCTDR following the diagnosis of multilevel cervical disc herniation or stenosis. Numeric Rating Scale (NRS), range of motion (ROM) at both C2-7 segment and TDR implanted levels, and location of COR at TDR level were evaluated at pre- and post-MCTDR. These parameters were compared between patients who experienced successful and unsuccessful pain relief. The inherent CORs relatively at ventro-cranial coordinates have demonstrated significant migrations to dorso-caudal location, more prominent shifts for the successful group, after MCTDR switch. The unsuccessful group showed markedly reduced C2-7 ROM and reduced angular improvement at C2-7 as well as MCTDR level in comparison with the successful group. Postoperative C2-7 ROM was related to postoperative COR along the X axis. The determinant for clinical success after MCTDR, other than mere preservation of the ROM both at C2-7 and TDR levels, was restoration of COR from ventro-cranial location close to normal coordinates by posterior and inferior shifts. The position of COR along the X axis after MCTDR was important factor to determine maintenance of C2-7 ROM. [ABSTRACT FROM AUTHOR]

In contrast to cervical discectomy and fusion, total disc replacement (TDR) aims at preserving the motion at the treated vertebral level. Spinal motion is commonly evaluated with the range of motion (ROM). However, more qualitative information about cervical kinematics before and after TDR is still lacking. The aim of this in vitro study was to investigate the influence of cervical TDR on ROM, instantaneous centers of rotation (ICR) and three-dimensional helical axes. An in vitro study with human spine specimens under pure moment loading was conducted to evaluate the kinematics of the intact cervical spine and compare it to cervical TDR. Six fresh frozen human cervical specimens (C4–5, median age 28 years, range 19–47 years, two female and four male) were biomechanically characterized in the intact state and after implantation of a cervical disc prosthesis (MOVE-C, NGMedical, Germany). To mimic in vivo conditions regarding temperature and humidity, water steam was used to create a warm and humid test environment with 37°C. Each specimen was quasistatically loaded with pure moments up to ±2.5 Nm in flexion/extension (FE), lateral bending (LB) and axial rotation (AR) in a universal spine tester for 3.5 cycles at 1 °/s. For each third cycle of motion the ROM was evaluated and an established method was used to determine the helical axis and COR and to project them into three planar X-rays. Statistical analysis was conducted using a Friedman-test and post hoc correction with Dunn-Bonferroni-tests (p<.05). After TDR, total ROM was increased in FE from 19.1° to 20.1°, decreased in LB from 14.6° to 12.6° and decreased in AR from 17.7° to 15.5°. No statistical differences between the primary ROM in the intact condition and ROM after TDR were detected. Coupled rotation between LB and AR were also maintained. The position and orientation of the helical axes after cervical TDR was in good agreement with the results of the intact specimens in all three motion directions. The ICR in FE and AR before and after TDR closely matched, while in LB the ICR after TDR were more caudal. The intact in vitro kinematics we found also resembled in vivo results of healthy individuals. The results of this in vitro study highlight the potential of artificial cervical disc implants to replicate the quantity as well as the quality of motion of the intact cervical spine. Physiological motion preservation was a driving factor in the development of cervical TDR. Our results demonstrate the potential of cervical TDR to replicate in vivo kinematics in all three motion directions. [ABSTRACT FROM AUTHOR]

The burden of disease regarding lumbar and cervical spine pain is a long-standing, pervasive problem within medicine that has yet to be resolved. Specifically, neck and back pain are associated with chronic pain, disability, and exorbitant health care use worldwide, which have only been exacerbated by the increase in overall life years and chronic disease. Traditionally, patients with significant pain and disability secondary to disease of either the cervical or lumbar spine are treated via fusion or discectomy. Although these interventions have proved curative in the short-term, numerous longitudinal studies evaluating the efficacy of traditional management have reported severe impairment of normal spinal range of motion, as well as postoperative complications, including neurologic injury, radiculopathy, osteolysis, subsidence, and infection, paired with less than desirable reoperation rates. Consequently, there is a call for innovation and improvement in the treatment of lumbar and cervical spine pain, which may be answered by a modern technique known as intervertebral disc arthroplasty, or total disc replacement (TDR). Thus, this review aims to describe the management strategy of TDR and to explore updated considerations for its use in practice, both to help guide clinical decision making. [ABSTRACT FROM AUTHOR]

BACKGROUND: The treatment of cervical spondylosis with total disc replacement can retain the range of motion of the cervical lesion segment and can effectively improve the symptoms of cervical spondylosis with sympathetic symptoms. OBJECTIVE: To investigate the clinical efficacy of total disc replacement for cervical spondylosis with sympathetic symptoms. METHODS: Retrospective analysis was made on 56 patients with cervical spondylosis with obvious sympathetic symptoms such as dizziness and headache who were operated on from December 2018 to December 2021. The sagittal parameters of the cervical spine before, 3 months after surgery and at the last followup were observed and compared, including cervical sympathetic symptom score and Japanese Orthopaedic Association Scores, operation segment angle, C2- C7 Cobb angle, C2-C7 sagittal vertical axis and T1 slope. The correlation between the changes in sympathetic symptoms and Japanese Orthopaedic Association Scores before and after surgery and the changes in cervical sagittal parameters before and after surgery was analyzed. RESULTS AND CONCLUSION: (1) All patients showed improvement in sympathetic symptoms after surgery, and the sympathetic symptom scores and Japanese Orthopaedic Association Scores were significantly improved at 3 months and at the last follow-up compared with those before surgery (P < 0.05), but Japanese Orthopaedic Association Scores did not show significant differences at the last follow-up compared with those at 3 months after surgery (P > 0.05). (2) The cervical sagittal parameters increased at 3 months and at the last follow-up compared with those before surgery, but not at the last follow-up compared with those at 3 months after surgery (P > 0.05). (3) The pre- and post-operative change values of sympathetic symptom scores significantly correlated with the preand post-operative change values of operation segment angle and C2-7 Cobb angle (P < 0.05). (4) The results indicate that total disc replacement has a good effect in the treatment of cervical spondylosis with sympathetic symptoms, which is conducive to restoring the sagittal parameters of the cervical spine and alleviating the sympathetic symptoms of patients. [ABSTRACT FROM AUTHOR]

Anterior cervical discectomy and fusion (ACDF) is the leading surgical treatment for cervical radiculopathy. However, ACDF surgery has been suggested for to accelerate the degeneration of the adjacent cervical discs, which causes so-called adjacent segment disease (ASD). Over the past 2 decades, total disc replacement (TDR)/cervical disc arthroplasty (CDA) has become an increasingly common method for treating degenerative cervical diseases. The rationale is that a synthetic disc prosthesis may preserve motion at the operated level, which is expected to lead to reduced stress on the other cervical levels and thus decrease the risk of developing ASD. However, since the method was first introduced in the early 2000s, the long-term outcome after it is still not completely understood. Our goal was to compare the long-term outcomes of TDR and ACDF procedures. Retrospective case-control study. All patients who underwent TDR due to degenerative cervical disease at Helsinki University Hospital between 2006 and 2012 (38 patients) and matched control patients who underwent ACDF during this period (76 patients) for degenerative disc disease. The primary outcome measure was the rate of reoperations and further cervical surgeries. Secondary outcome measures included neck symptoms (Neck Disability Index, or NDI), health-related quality of life (EQ-5D-3L), satisfaction with the surgery, radiological outcomes, and employment status. The medical records of all patients who underwent TDR due to degenerative cervical disease at Helsinki University Hospital between 2006 and 2012 and those of the matched control patients were analyzed retrospectively. Questionnaires were sent to all available patients at the end of the follow-up (median 14 years) to evaluate their employment status, levels of satisfaction with the surgery, current neck symptoms, and health-related quality of life. Radiological outcomes were evaluated from the cervical plain radiographs, which were taken either at the end of the follow-up as a part of the present study or earlier on for other clinical reasons, but at least 2 years after index surgery. The total rate of reoperations and further cervical surgeries during the follow-up of a median of 14 years was 7/38 (18%) in the TDR group and 6/76 (8%) in the ACDF group (p=.096, ns.). Total disc replacement patients were reoperated earlier, and the 5-year reoperation rate was significantly higher in the TDR group (11% vs 1.3%, p=.026). None of the TDR patients underwent further cervical surgery more than 6 years after index surgery, whereas 5/6 (83%) of the reoperated ACDF patients were reoperated after that time. There were no significant differences in the NDIs between the patient groups. The employment rate and health-related quality of life were slightly higher in the TDR group, but the differences were statistically nonsignificant. TDR was significantly better at maintaining the angular range of motion at the operated level, and the fusion rate was significantly lower among this group. There were no significant differences in the long-term outcomes of ACDF and TDR when measured by reoperation rates, employment status, NDI, EuroQoL, and satisfaction with surgery. Reoperation rate and, on the other hand, employment rate and health-related quality of life, were higher in the TDR group, but the differences were statistically nonsignificant. However, TDR patients were reoperated earlier, and the 5-year reoperation rate was significantly higher in the TDR group. Randomized long-term studies in which these methods are compared are needed to further clarify the differences between them. [ABSTRACT FROM AUTHOR]

Background Context: Cervical disc replacement (CDR) aims to restore motion of the treated level to reduce the risk of adjacent segment disease (ASD) compared with spinal fusion. However, first‐generation articulating devices are unable to mimic the complex deformation kinematics of a natural disc. Thus, a biomimetic artificial intervertebral CDR (bioAID), containing a hydroxyethylmethacrylate (HEMA)—sodium methacrylate (NaMA) hydrogel core representing the nucleus pulposus, an ultra‐high‐molecular‐weight‐polyethylene fiber jacket as annulus fibrosus, and titanium endplates with pins for primary mechanical fixation, was developed. Purpose: To assess the initial biomechanical effect of the bioAID on the kinematic behavior of the canine spine, an ex vivo biomechanical study in 6‐degrees‐of‐freedom was performed. Study Design: A canine cadaveric biomechanical study. Methods: Six cadaveric canine specimens (C3‐C6) were tested in flexion‐extension (FE), lateral bending (LB) axial rotation (AR) using a spine tester in three conditions: intact, after C4‐C5 disc replacement with bioAID, and after C4‐C5 interbody fusion. A hybrid protocol was used where first the intact spines were subjected to a pure moment of ±1 Nm, whereafter the treated spines were subjected to the full range of motion (ROM) of the intact condition. 3D segmental motions at all levels were measured while recording the reaction torsion. Biomechanical parameters studied included ROM, neutral zone (NZ), and intradiscal pressure (IDP) at the adjacent cranial level (C3‐C4). Results: The bioAID retained the sigmoid shape of the moment‐rotation curves with a NZ similar to the intact condition in LB and FE. Additionally, the normalized ROMs at the bioAID‐treated level were statistically equivalent to intact during FE and AR while slightly decreased in LB. At the two adjacent levels, ROMs showed similar values for the intact compared to the bioAID for FE and AR and an increase in LB. In contrast, levels adjacent to the fused segment showed an increased motion in FE and LB as compensation for the loss of motion at the treated level. The IDP at the adjacent C3‐C4 level after implantation of bioAID was close to intact values. After fusion, increased IDP was found compared with intact but did not reach statistical significance. Conclusion: This study indicates that the bioAID can mimic the kinematic behavior of the replaced intervertebral disc and preserves that for the adjacent levels better than fusion. As a result, CDR using the novel bioAID is a promising alternative treatment for replacing severely degenerated intervertebral discs. [ABSTRACT FROM AUTHOR]

Abstract Background Hybrid construction (HC) may be an ideal surgical strategy than noncontinuous total disc replacement (TDR) and noncontinuous anterior cervical discectomy and fusion (ACDF) in the treatment of noncontinuous cervical spondylopathy. However, there is still no consensus on the segmental selection for ACDF or TDR in HC. The study aims to analyse the effects of different segment selection of TDR and ACDF on cervical biomechanical characteristics after HC surgery. Methods Twelve FEMs of C2–C7 were constructed based on CT images of 12 mild cervical spondylopathy volunteers. Two kinds of HC were introduced in our study: Fusion-arthroplasty group (Group 1), upper-level (C3/4) ACDF, and lower-level TDR (C5/6); Arthroplasty-fusion group (Group 2), upper-level (C3/4) TDR and lower-level ACDF (C5/6). The follow-load technique was simulated by applying an axial initial load of 73.6 N through the motion centre of FEM. A bending moment of 1.0 Nm was applied to the centre of C2 in all FEMs. Statistical analysis was carried out by SPSS 26.0. The significance threshold was 5% (P

Purpose: It is sometimes anticipated that patients with prior spine surgery will have a compromised outcome from future procedures. The purpose of this study was to compare TDR outcomes in patients with prior lumbar spine surgery to those with no previous surgery. Methods: Post hoc analysis was performed on 5-year follow-up data collected prospectively in the multi-centre FDA-regulated trial for the activL® Artificial Disc which involved 376 patients treated for single-level symptomatic disc degeneration. Clinical outcome measures included the Oswestry Disability Index (ODI), visual analog scales (VAS) assessing back and leg pain, SF-36, adverse events, and re-operations. Radiographic outcomes included flexion/extension range of motion (ROM) and translation of the operated segment. Patients were divided into two groups: Prior Lumbar Surgery (PLS, n = 92) and No Prior Lumbar Surgery (NPLS, n = 284). Results: Baseline demographics were similar in the two groups. ODI, VAS, and SF-36 Physical Component Scale scores improved significantly (p < 0.05) from baseline in both groups with improvements maintained through 5-year post-TDR with no significant differences between groups. There were no statistically significant differences in rates of serious device-related events, procedure-related events, or re-operations. While ROM was significantly less prior to TDR surgery in the PLS group, there was no significant difference in ROM at post-operative points. Conclusion: Prior lumbar spine surgery was not associated with compromised outcomes following TDR. These results are in line with reports from earlier studies with shorter follow-up, finding that non-destabilizing prior surgery is not a contra-indication for TDR provided that selection criteria are met. Level of Evidence I: Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding. [ABSTRACT FROM AUTHOR]

Abstract Background Context Cervical disc replacement (CDR) aims to restore motion of the treated level to reduce the risk of adjacent segment disease (ASD) compared with spinal fusion. However, first‐generation articulating devices are unable to mimic the complex deformation kinematics of a natural disc. Thus, a biomimetic artificial intervertebral CDR (bioAID), containing a hydroxyethylmethacrylate (HEMA)—sodium methacrylate (NaMA) hydrogel core representing the nucleus pulposus, an ultra‐high‐molecular‐weight‐polyethylene fiber jacket as annulus fibrosus, and titanium endplates with pins for primary mechanical fixation, was developed. Purpose To assess the initial biomechanical effect of the bioAID on the kinematic behavior of the canine spine, an ex vivo biomechanical study in 6‐degrees‐of‐freedom was performed. Study Design A canine cadaveric biomechanical study. Methods Six cadaveric canine specimens (C3‐C6) were tested in flexion‐extension (FE), lateral bending (LB) axial rotation (AR) using a spine tester in three conditions: intact, after C4‐C5 disc replacement with bioAID, and after C4‐C5 interbody fusion. A hybrid protocol was used where first the intact spines were subjected to a pure moment of ±1 Nm, whereafter the treated spines were subjected to the full range of motion (ROM) of the intact condition. 3D segmental motions at all levels were measured while recording the reaction torsion. Biomechanical parameters studied included ROM, neutral zone (NZ), and intradiscal pressure (IDP) at the adjacent cranial level (C3‐C4). Results The bioAID retained the sigmoid shape of the moment‐rotation curves with a NZ similar to the intact condition in LB and FE. Additionally, the normalized ROMs at the bioAID‐treated level were statistically equivalent to intact during FE and AR while slightly decreased in LB. At the two adjacent levels, ROMs showed similar values for the intact compared to the bioAID for FE and AR and an increase in LB. In contrast, levels adjacent to the fused segment showed an increased motion in FE and LB as compensation for the loss of motion at the treated level. The IDP at the adjacent C3‐C4 level after implantation of bioAID was close to intact values. After fusion, increased IDP was found compared with intact but did not reach statistical significance. Conclusion This study indicates that the bioAID can mimic the kinematic behavior of the replaced intervertebral disc and preserves that for the adjacent levels better than fusion. As a result, CDR using the novel bioAID is a promising alternative treatment for replacing severely degenerated intervertebral discs.

While cervical total artificial disc replacement potentially preserves motion of the natural intervertebral disc (IVD), problems also arise involving alterations of the spinal biomechanics. A major challenge lies in restoring mechanics of the natural IVD with appropriate kinematics and biomimetic configuration. A biomimetic artificial IVD model is designed and fabricated using a 3D braided fibrous scaffold and a self‐healable hydrogel matrix. The artificial IVD is characterized by 3D four‐directional fibrous structure resembling natural annulus fibrosus and self‐healable hydrogel‐mimicking natural nucleus pulposus. In the compression tests, the artificial IVD exhibits reasonable mechanical behaviors and desired viscoelastic behaviors similar to the natural IVD. After fatigue loading of 5 million cycles, the artificial IVDs become stiffer, whereas the mechanical values remain within the reasonable range. Finite‐element analysis of the artificial IVD from mesoscale and macroscale analysis indicates the coherent load transfer through both the interconnections within the fiber mesh and the fiber–matrix interface, and the entire IVD shows a stress profilometry similar to natural IVD. In conclusion, a biomimetic prototype of artificial IVD with nature‐mimicking mechanics and structure is fabricated. The presence of interwoven fibrous mesh, hydrogel confinement, and proper interfacial adhesion is all essential for scalable production of the IVD.

Rupture of the elastic nucleus is one of the most critical challenges in total disc replacement (TDR). Smart polymers (SMPs) could be good candidates for TDR due to their unique properties such as self-healing, shape memory, adhesion control, adhesive capability and self-assembly. Herein, we investigate the behavior of SMPs as intervertebral discs (IVDs) under pure bending loading using analytical and numerical methods. For this purpose, the lumbar disc was considered as a cantilever beam and constitutive equation for pure bending mode using Euler-Bernoulli beam theory were developed in a full cycle of stress-free strain recovery. Numerical evaluation was performed to understand the effect of frozen volume fraction to determine the appropriate SMP for clinical evaluations. We conduct all analyses for the L4-L5 vertebral section because it is the most susceptible lumbar disc to damage. The numerical results show that SMPs with rescued frozen volume fraction are better representative for natural lumbar disc. Our results also indicate that SMPs that replace IVDs should be able to withstand at least 7.8° and 8.93° angle changes for pure bending and flexion-extension loads without any damage.

Background: Hybrid construction (HC) may be an ideal surgical strategy than noncontinuous total disc replacement (TDR) and noncontinuous anterior cervical discectomy and fusion (ACDF) in the treatment of noncontinuous cervical spondylopathy. However, there is still no consensus on the segmental selection for ACDF or TDR in HC. The study aims to analyse the effects of different segment selection of TDR and ACDF on cervical biomechanical characteristics after HC surgery. Methods: Twelve FEMs of C2–C7 were constructed based on CT images of 12 mild cervical spondylopathy volunteers. Two kinds of HC were introduced in our study: Fusion-arthroplasty group (Group 1), upper-level (C3/4) ACDF, and lower-level TDR (C5/6); Arthroplasty-fusion group (Group 2), upper-level (C3/4) TDR and lower-level ACDF (C5/6). The follow-load technique was simulated by applying an axial initial load of 73.6 N through the motion centre of FEM. A bending moment of 1.0 Nm was applied to the centre of C2 in all FEMs. Statistical analysis was carried out by SPSS 26.0. The significance threshold was 5% (P < 0.05). Results: In the comparison of ROMs between Group 1 and Group 2, the ROM in extension (P = 0.016), and lateral bending (P = 0.038) of C4/5 were significantly higher in Group 1 group. The average intervertebral disc pressures at C2/3 in all directions were significantly higher in Group 1 than those in Group 2 (P < 0.005). The average contact forces in facet joints of C2/3 (P = 0.007) were significantly more than that in Group 2; however, the average contact forces in facet joints of C6/7 (P < 0.001) in Group 1 group were significantly less than that in Group 2. Conclusions: Arthroplasty-fusion is preferred for intervertebral disc degeneration in adjacent upper segments. Fusion-arthroplasty is preferred for patients with lower intervertebral disc degeneration or lower posterior column degeneration. Trial registration: This research was registered in Chinese Clinical Trial Registry (ChiCTR1900020513). [ABSTRACT FROM AUTHOR]

Study Design: Prospective non-randomized single-center cohort study. Objectives: To analyze the quality of postoperative magnetic resonance imaging of 2 structurally different cervical disc arthroplasty devices at the index and adjacent levels. Methods: A non-randomized, comparative, prospective, single-center study included 40 patients (23 men and 17 women) aged 32 (26-40) years. Two study groups were utilized: in the first (n = 20), a titanium prosthesis was used; in the second (n = 20), a cobalt-chromium implant was used. Evaluation of MRI studies before and after surgery was performed using sagittal and axial T2 weighted images by 2 specialists who were blinded to the prosthesis that was used. To determine the quality of an MRI image, the classification of Jarvik 2000, the radiological and orthopedic scales for assessing artifacts were used. Results: There was good-to-excellent inter-observer agreement for all of the MR parameters used for the titanium and satisfactory-to-good for the cobalt chromium group. The analysis of the quality of postoperative imaging using the Jarvik 2000 scale showed a statistically significant deterioration in MR images in the cobalt chromium group (P < 0.001), compared to the titanium (P = 0.091). Following a single-level total arthroplasty, the titanium group had better MRI images according to radiological and orthopedic scales (P < 0.001). Conclusion: Titanium cervical disc arthroplasty devices result in superior postoperative MR imaging, as compared to cobalt chromium prostheses, as the latter significantly reduces image quality due to the pronounced ferromagnetic effect. [ABSTRACT FROM AUTHOR]

Objective This study aims to compare the impact of achieving an MCID or meeting preoperative expectations on patient satisfaction following cervical spine procedures. Methods A surgical database was retrospectively reviewed for cervical spine surgery patients from 2016 to 2020. Inclusion criteria were primary or revision, single- or multilevel cervical disc arthroplasty or anterior cervical discectomy and fusions (ACDF). Visual analogue scale (VAS) neck and arm pain was assessed preoperatively and postoperatively (6-week, 12-weeks, 6-months, 1-year). Preoperative patient expectation and postoperative satisfaction were recorded. MCID achievement was determined using previously established values. Expectations met and MCID achievement were compared as possible predictors of satisfaction. Results One hundred and six cervical spine patients were included. Both meeting expectations and achieving MCID were significant predictors of satisfaction for arm pain at 6-weeks and 12-weeks (all p≤0.007). Achieving MCID significantly predicted satisfaction for neck pain at all timepoints (all p≤0.007) and meeting expectations predicted satisfaction for neck pain at 6-weeks, 12-weeks, and 1-year (all p≤0.003). Comparison of coefficients revealed no significant difference in effect size between meeting expectations and achievement of MCID as predictors of patient satisfaction (all p>0.050). Conclusion MCID achievement and meeting expectations were significant predictors of satisfaction for neck pain and short-term arm pain. Both measures may be similarly useful for interpretation of patient outcomes and the optimal choice of metric may depend on practice-specific factors.

Introduction: The correlation between cervical alignment and clinical outcome of total disc replacement (TDR) surgery is arguable. We believe that this conflict exists because the parameters that influence the biomechanics of the cervical spine are not well understood, specifically the effect of TDR on different cervical alignments. Methods: A validated osseo-ligamentous model from C2-C7 was used in this study. The C2-C7 Cobb angle of the base model was modified to represent: lordotic (−10°), straight (0°), and kyphotic (+10°) cervical alignment. The TDR surgery was simulated at the C5-C6 segment. The range of motion (ROM), intradiscal pressure, annular stresses, and facet loads were computed for all the models. Results: The ROM results demonstrated kyphotic alignment after TDR surgery to be the most mobile when compared to intact base model (41% higher in flexion–extension, 51% higher in lateral bending, and 27% higher in axial rotation) followed by straight and lordotic alignment, respectively. The annular stresses for the kyphotic alignment when compared to intact base model were higher at the index level (33% higher in flexion–extension and 48% higher in lateral bending) compared to other alignments. The lordotic model demonstrated higher facet contact forces at the index level (75% higher in extension than kyphotic alignment, 51% higher in lateral bending than kyphotic alignment, and 78% higher in axial rotation than kyphotic alignment) when compared among the three alignment models. Conclusion: Preoperative cervical alignment should be an integral part of surgical planning for TDR surgery as different cervical alignments may significantly alter the postsurgical outcomes.

Introduction: Cervical total disc replacement (CTDR) is an alternative to anterior cervical discectomy and fusion for select patients that may preserve range of motion and reduce adjacent segment disease. Various CTDR prostheses are available; however, comparative data are limited. This study aimed to compare the short-term kinematic and radiological parameters of the M6-C, Mobi-C, and the CP-ESP prostheses. Methods: This retrospective cohort study included patients treated with CTDR between March 2005 and October 2020 at a single institution. Patients were included if their follow-up assessment included lateral erect and flexion/extension radiographs. The primary outcome assessed at 3-months postoperatively was range of motion, measured by the difference in functional spinal unit angle between flexion and extension. Results: A total of 131 CTDR levels (120 patients, 46.2 ± 10.1 years, 57% male) were included. Prostheses implanted included the M6-C (n = 52), Mobi-C (n = 54), and CP-ESP (n = 25). Range of motion varied significantly (8.2° ± 4.4° vs. 10.9° ± 4.7° vs. 6.1° ± 2.7°, P < 0.001). On post hoc analysis, the Mobi-C prosthesis demonstrated a significantly greater range of motion than either the M6-C prosthesis (P = 0.003) or CP-ESP (P < 0.001). Conclusion: Although the optimal range of motion for CTDR has not been established, short-term differences in the range of motion may guide the selection of CTDR prosthesis. Further studies with longer follow-up and consideration of clinical outcome measures are necessary.

The intact intervertebral disc is a six-freedom degree elastic deformation structure with shock absorption. “Ball-and-socket” TDR do not reproduce these properties inducing zygapophyseal joint overload. Elastomeric TDRs reproduce better normal disc kinematics, but repeated core deformation causes its degeneration. We aimed to create a new TDR (ADDISC) reproducing healthy disc features. We designed TDR, analyzed (Finite Element Analysis), and measured every 500,000 cycles for 10 million cycles of the flexion-extension, lateral bending, and axial rotation cyclic compression bench-testing. In the inlay case, we weighted it and measured its deformation.ADDISC has two semi-spherical articular surfaces, one rotation centre for flexion, another for extension, the third for lateral bending, and a polycarbonate urethane inlay providing shock absorption. The first contact is between PCU and metal surfaces. There is no metal-metal contact up to 2000 N, and CoCr28Mo6 absorbs the load. After 10 million cycles at 1.2–2.0 kN loads, wear 140.96 mg (35.50 mm3), but no implant failures. Our TDR has a physiological motion range due to its articular surfaces' shape and the PCU inlay bumpers, minimizing the facet joint overload. ADDISC mimics healthy disc biomechanics and Instantaneous Rotation Center, absorbs shock, reduces wear, and has excellent long-term endurance.

Purpose: The purpose of this study was to investigate reasons and their frequency for why spine surgeons subspecializing in total disc replacement (TDR) performed lumbar fusion rather than TDR.Methods: The study was based on a consecutive series of 515 patients undergoing lumbar TDR or fusion during a 5-year period by three surgeons specializing in TDR. For each fusion patient, the reason for not performing TDR was recorded.Results: TDR was performed in 65.4% (n = 337) of patients and the remaining 34.6% (n = 178) underwent anterior lumbar interbody fusion (ALIF ± posterior instrumentation). Of the 178 fusion patients, the most common reason for fusion was combined factors related to severe degenerative changes (n = 59, 11.5% of the study population). The second most common reason was > Grade 1 spondylolisthesis (n = 32, 6.2%), followed by insurance non-coverage (n = 24, 4.7%), and osteopenia/osteoporosis (n = 13, 2.5%). Fusion patients were significantly older than TDR patients (52.5 vs. 41.6 years; p < 0.01). There was no significant difference with respect to gender (41.2% female vs. 43.8% female, p > 0.05) or the percentage of patients with single-level surgery (61.2% vs. 56.7%, p > 0.05).Conclusion: The most common reason for not performing lumbar TDR was related to anatomic factors that may compromise stability of the operated segment and/or TDR functionality. The older age of fusion patients may be related to these factors. This study found that many patients are appropriate candidates for lumbar TDR. However, even among TDR subspecialists, fusion is preferred when there are factors that cannot be addressed with TDR and/or may compromise implant functionality. [ABSTRACT FROM AUTHOR]

Objective: This study aims to compare the impact of 3 surgical techniques-stand-alone cage placement (SAC), anterior cervical plate (ACP) fixation, and total disc replacement (TDR)-on cervical lordosis restoration and segmental height after anterior cervical discectomy at C5-6 level. To eliminate the effect of lordosis between different levels, patients operated on at the same level were included in the study. Restoring cervical lordosis is crucial for improving patient outcomes, including pain reduction and preventing mechanical complications., Methods: A retrospective screening of 89 patients who underwent single-level C5-6 surgery between 2011 and 2021 was analyzed. Patients were categorized into 3 groups based on the surgical technique used: SAC, ACP, or TDR. Lordotic angles and segmental heights were measured preoperatively, first-month follow-up, and at the 24-month follow-up. Statistical analysis was conducted using the Wilcoxon Signed Rank test and ANOVA, with a significance threshold set at P < 0.05., Results: All 3 techniques resulted in significant early and late postoperative increases in both global and segmental lordosis. The early postoperative height gain was most pronounced in the ACP group. However, no significant differences in lordosis or height preservation were observed among the groups at the 24-month follow-up. These findings align with previous studies, indicating comparable long-term outcomes across these surgical approaches., Conclusions: SAC placement, ACP fixation, and TDR, all effectively restore cervical lordosis and segmental height after anterior cervical discectomy at the C5-6 level. Despite early differences, the long-term results were similar, suggesting that the choice of technique should be based on individual patient needs and specific surgical considerations., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Study Design: Retrospective cohort analysis., Objective: To compare clinical outcomes of outpatient anterior cervical disk replacements (ACDR) performed in free-standing private ambulatory surgery centers versus tertiary hospital centers., Summary of Background Data: ACDR is an increasingly popular technique for treating various degenerative pathologies of the cervical spine. There has been an increase in the utilization of ambulatory surgery centers (ASCs) for outpatient cervical procedures due to economic and convenience benefits; however, a paucity of literature exists in evaluating long-term safety and efficacy of ACDRs performed in ASCs versus outpatient hospital centers., Methods: A retrospective cohort review of all patients undergoing 1- or 2-level ACDRs at 2 outpatient ASCs and 4 tertiary care medical centers from 2012 to 2020, with a minimum follow-up of 24 months, was performed. Approval by each patient's insurance and patient preference determined distribution into an ASC or non-ASC. Demographics, perioperative data, length of follow-up, complications, and revision rates were analyzed. Functional outcomes were assessed using VAS and NDI at follow-up visits., Results: One hundred seventeen patients were included (65 non-ASC and 52 ASC). There were no significant differences in demographics or length of follow-up between the cohorts. ASC patients had significantly lower operative times (ASC: 89.5 minutes vs. non-ASC: 110.5 minutes, P <0.001) and mean blood loss (ASC: 17.5 mL vs. non-ASC: 25.3 mL, P <0.001). No significant differences were observed in rates of dysphagia (ASC: 21.2% vs. non-ASC: 15.6%, P <0.001), infection (ASC: 0.0% vs. non-ASC: 1.6%, P =0.202), ASD (ASC: 1.9% vs. non-ASC: 1.6%, P =0.202), or revision (ASC: 1.9% vs. non-ASC: 0.0%, P =0.262). Both groups demonstrated significant improvements in VAS and NDI scores ( P <0.001), but no significant differences in the degree of improvement were observed., Conclusions: Our 2-year results demonstrate that ACDRs performed in ASCs may offer the advantages of reduced operative time and blood loss without an increased risk of postoperative complications., Competing Interests: A.E. receives grants/research support from NuVasive and Stryker Spine. K.H. is a consultant for Stryker Spine. The remaining authors declare no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Thromboembolic complications in anterior lumbar spinal surgery can rarely result in limb loss. Iliac vessel retraction can temporarily occlude the iliac artery risking thromboembolic sequelae. Studies estimate the incidence of iliac artery thrombosis at 0.45%. Brief intraoperative heparinization can potentially mitigate this risk. We aim to quantify the incidence of temporary iliac artery occlusion (TIAO) and examine its association with potential risk factors (sex, BMI, target disc level, and type of prosthesis)., Methods: Retrospective analysis of consecutive patients undergoing anterior lumbar spinal surgery by a single vascular surgeon and 5 spinal neurosurgeons between 2009 and 2022. Patients underwent single or double-level total disc replacement (TDR); single, double, or triple-level anterior lumbar interbody fusion (ALIF); or hybrid procedure (combined cranial TDR and caudal ALIF). A pulse oximeter monitored bilateral second toes perfusion. Loss of the waveform, combined with a nonpalpable external iliac artery pulse distal to the retractors was defined as TIAO of the ipsilateral artery. Heparin was administered if TIAO developed., Results: Of 605 patients (318 males, 287 females), TIAO occurred in 176 patients (29.1%). TIAO occurred in 13.5% of the 377 patients who underwent single or multilevel ALIF and in 42.7% of the 110 patients who underwent single or multilevel TDR (p=.004). In single-level surgery at L5/S1, TIAO occurred in 3.1% of patients. In single-level surgery at L4/5, TIAO occurred in 65.2% of patients overall; the rate was higher for TDR than for ALIF (74.6% vs. 48.5%; p=.01). The TIAO rate was 44.3% in multilevel procedures and 66.1% in hybrid procedures. No patient developed postoperative thrombotic iliac artery occlusion or embolic complications., Conclusions: TIAO occurred frequently during anterior lumbar exposure (29%). Anterior spinal exposure at L4/5 had a high incidence of TIAO, particularly for TDR, in contrast to L5/S1., Competing Interests: The authors report no conflicts of interest for this study., (© 2024 The Authors.)

Cervical disc replacement is an alternative option to an anterior cervical discectomy and fusion for cervical spine degenerative disease. We present the first reported case of a progressively worsening symptomatic spinal cord compression secondary to migration of the nucleus from a Mobi-C total disc replacement. [ABSTRACT FROM AUTHOR]

Introduction: The correlation between cervical alignment and clinical outcome of total disc replacement (TDR) surgery is arguable. We believe that this conflict exists because the parameters that influence the biomechanics of the cervical spine are not well understood, specifically the effect of TDR on different cervical alignments. Methods: A validated osseo-ligamentous model from C2-C7 was used in this study. The C2-C7 Cobb angle of the base model was modified to represent: lordotic (−10°), straight (0°), and kyphotic (+10°) cervical alignment. The TDR surgery was simulated at the C5-C6 segment. The range of motion (ROM), intradiscal pressure, annular stresses, and facet loads were computed for all the models. Results: The ROM results demonstrated kyphotic alignment after TDR surgery to be the most mobile when compared to intact base model (41% higher in flexion–extension, 51% higher in lateral bending, and 27% higher in axial rotation) followed by straight and lordotic alignment, respectively. The annular stresses for the kyphotic alignment when compared to intact base model were higher at the index level (33% higher in flexion–extension and 48% higher in lateral bending) compared to other alignments. The lordotic model demonstrated higher facet contact forces at the index level (75% higher in extension than kyphotic alignment, 51% higher in lateral bending than kyphotic alignment, and 78% higher in axial rotation than kyphotic alignment) when compared among the three alignment models. Conclusion: Preoperative cervical alignment should be an integral part of surgical planning for TDR surgery as different cervical alignments may significantly alter the postsurgical outcomes. [ABSTRACT FROM AUTHOR]

Study Design The study examined and compared four artificial cervical disks using validated finite element models. Purpose To compare and contrast the biomechanical behavior of four artificial cervical disks by determining the external (range of motion) and internal (facet force and intradiscal pressure) responses following cervical disc arthroplasty (CDA) and to elucidate any device design effects on cervical biomechanics. Overview of Literature Despite CDA’s increasing popularity most studies compare the CDA procedure with anterior cervical discectomy and fusion. There is little comparative evaluation of different artificial disks and, therefore, little understanding of how varying disk designs may influence spinal biomechanics. Methods A validated C2–T1 finite element model was subjected to flexion-extension. CDAs were simulated at the C5–C6 level with the Secure-C, Mobi-C, Prestige LP, and Prodisc C prosthetic disks. We used a hybrid loading protocol to apply sagittal moments. Normalized motions at the index and adjacent levels, and intradiscal pressures and facet column loads were also obtained. Results The ranges of motion at the index level increased after CDA. The Mobi-C prosthesis demonstrated the highest amount of flexion, followed by the Secure-C, Prestige LP, and Prodisc C. The Secure-C demonstrated the highest amount of extension, followed by the Mobi-C, Prodisc C, and Prestige LP. The motion decreased at the rostral and caudal adjacent levels. Facet forces increased at the index level and decreased at the rostral and caudal adjacent levels following CDA. Intradiscal pressures decreased at the adjacent levels for the Mobi-C, Secure-C, and Prodisc C. Conversely, the use of the Prestige LP increased intradiscal pressure at both adjacent levels. Conclusions While all artificial disks were useful in restoring the index level motion, the Secure-C and Mobi-C translating abilities allowed for lower intradiscal pressures at the adjacent segments and may be the driving mechanism for minimizing adjacent segment degenerative arthritic changes. The facet joint integrity should also be considered in the clinical decision-making process for CDA selection.

Abstract Objective We aimed to evaluate reliability, radiological outcomes, and the impacts of anterior cervical hybrid construction on the adjacent segments for the multilevel cervical degenerative disc disease (mCDDD) and spondylotic spinal stenosis (SSS). Methods A retrospective analysis was performed using data extracted from the medical files of 195 patients (105 males, 90 females; mean age: 47.7 years). From 2008 to 2018, these patients underwent anterior cervical hybrid construction for symptomatic contiguous at least 2-level cervical degenerative disc diseases and cervical spondylosis. Clinical and radiological data including Neck Disability Index (NDI), visual analogue scale (VAS), local cervical degenerative disk disease in adjacent segments on magnetic resonance imaging (MRI) views, and complications were reviewed. Results The mean clinical and radiological follow-up was 45.2 months (range 24 to 102). Radiculopathy and/or myelopathy were the main clinical problems in all patients. The mean VAS scores of HC for arm pain were 7.4 ± 0.8 preoperatively; 2.8 ± 0.6, 1 month after surgery; 2.3 ± 0.6, 6 months after surgery; 1.8 ± 0.6, 12 month after surgery; and 1.6 ± 0.6, 24 months after surgery. The mean NDI scores (mean ± SD) of HC significantly improved after surgery (on admission, 57.2 ± 5.5%; 1 month after surgery, 27.35 ± 5.3%; 6 month after surgery, 21.43 ± 2.8%; 12 months after surgery, 21.9 ± 2.3%; 24 months after surgery, 20.6 ± 2.6%, p = 0.006). Hoarseness and dysphagia were the most common complications and osteophyte formation was the most frequent radiographic change. Conclusion Anterior cervical hybrid construction appears to be an acceptable option in the management of multilevel cervical degenerative disc diseases and spondylotic spinal stenosis.

Objective. To compare the effectiveness of surgical methods for treating patients with recurrent lumbar disc herniation. Material and Methods. The sample consisted of 160 patients operated on in 2014–2019 for recurrent lumbar disc herniation by percutaneous endoscopic discectomy (Group 1), microsurgical discectomy (Group 2), single-level transforaminal interbody fusion (Group 3) and single-level total intervertebral disc replacement (Group 4). The effectiveness of surgical treatment was evaluated using the NRS-11, ODI, and MacNab questionnaires. Results. Assessment of the pain syndrome severity and the vital activity level of patients revealed significant (p < 0.05) differences in favor of total intervertebral disc replacement. Excellent and good outcomes after arthroplasty according to MacNab criteria were noted in all patients in this group. Similar outcomes were reported in 77.5 % (31/40) of patients in the TLIF group, in 75.1 % (24/32) of patients in the percutaneous endoscopic discectomy group and in 72.6 % (45/62) of patients in the microdiscectomy group. The operation time and length of hospital stay were shorter in the endoscopic and microsurgical discectomy groups (p < 0.001). However, the lower incidence of complications and reoperations was observed in groups of posterior interbody fusion and arthroplasty (p > 0.05). Conclusion. Arthroplasty with the M6-L implant expands the possibilities of surgery for recurrent lumbar disc herniation. Total intervertebral disc replacement and posterior interbody fusion for recurrent lumbar disc herniation are more effective in comparison with decompressive operations, which is reflected in the improvement of clinical treatment outcomes, reduction of perioperative complications and frequency of repeated interventions.

• We present a numerical model of the mechanical behaviour of lumbar spine at healthy and after total disc replacement under low-energy impacts equivalent to physiological loads. • The mechanical behaviour of bone tissue is described using the poroelastic model (accounting for the interstitial biological fluid) within the method of movable cellular automata (discrete elements). • The results obtained with an artificial disc (with keel-type fixation) showed that the use of this type of endoprosthesis in healthy bone tissues allows to reproduce the function of the natural intervertebral disc and does not contribute to the development of neoplastic processes. • In the case of an artificial disc with osteoporosis of bone tissues, there is a zone with increased risk of tissue resorption and development of neoplastic processes in the area near the contact of the implant attachment. This circumstance can be compensated by increasing the loading level. Degenerative diseases of the spine have a negative impact on the quality of life of patients. This study presents the results of numerical modelling of the mechanical behaviour of the lumbar spine with patient-specific conditions at physiological loads. This paper aims to numerically study the influence of degenerative changes in the spine and the presence of an endoprosthesis on the creation of conditions for tissue regeneration. A numerical model of the mechanical behaviour of lumbar spine at healthy and after total disc replacement under low-energy impacts equivalent to physiological loads is presented. The model is based on the movable cellular automaton method (discrete elements), where the mechanical behaviour of bone tissue is described using the Biot poroelasticity accounting for the presence and transfer of interstitial biological fluid. The nutritional pathways of the intervertebral disc in cases of healthy and osteoporotic bone tissues were predicted based on the analysis of the simulation results according to the mechanobiological principles. Simulation of total disc replacement showed that osseointegration of the artificial disc plates occurs only in healthy bone tissue. With total disc replacement in a patient with osteoporosis, there is an area of increased risk of bone resorption in the near-contact area, approximately 1 mm wide, around the fixators. Dynamic loads may improve the osseointegration of the implant in pathological conditions of the bone tissue. The results obtained in the case of healthy spine and osteoporotic bone tissues correspond to the experimental data on biomechanics and possible methods of IVD regeneration from the position of mechanobiological principles. The results obtained with an artificial disc (with keel-type fixation) showed that the use of this type of endoprosthesis in healthy bone tissues allows to reproduce the function of the natural intervertebral disc and does not contribute to the development of neoplastic processes. In the case of an artificial disc with osteoporosis of bone tissues, there is a zone with increased risk of tissue resorption and development of neoplastic processes in the area near the contact of the implant attachment. This circumstance can be compensated by increasing the loading level. [ABSTRACT FROM AUTHOR]

Most ball-in-socket artificial lumbar disc implanted in the spine result in increased hypermobility of the operative level and overloading of the facet joint. A finite element model was established and validated for the lumbar spine (L1-L5). The structure of the Mobidisc prosthesis was modified, resulting in the development of two new intervertebral disc prostheses, Movcore and Mcopro. The prostheses were implanted into the L3/L4 level to simulate total disc replacement, and the biomechanical properties of the lumbar spine model were analyzed after the operation. Following the implantation of the prostheses, the mobility of operative level, peak stress of lumbar spine models, and peak stress of facet joint increased. The performance of mobility was found to be more similar between Movcore and Mobidisc. The mobility and facet joint peak stress of the Mcopro model decreased progressively with an increase in the Young's modulus of the artificial annulus during flexion, extension, and lateral bending. Among all the models, the Mcopro50 model had the mobility closest to the intact model. It showed a 3% decrease in flexion, equal range of motion in extension, a 9% increase in left lateral bending, a 7% increase in right lateral bending, and a 3% decrease in axial rotation. The feasibility of the new intervertebral disc prostheses, Movcore and Mcopro, has been established. The Mcopro prosthesis, which features an artificial annular structure, offers significant advantages in terms of reduced mobility of the operative level and peak stress of facet joint. • Material assignment to skeletal models based on grayscale values of the computed temography image. • Designed two new disc prostheses. • Biomechanical properties of prostheses of different structures. • Influence on prosthesis biomechanics of material properties of artificial annulus structure. [ABSTRACT FROM AUTHOR]

Purpose: Our study aimed to evaluate non-inferiority of ProDisc-C to anterior cervical discectomy and fusion (ACDF) in terms of clinical outcomes and incidence of adjacent segment disease (ASD) at 24-months post-surgery in Asian patients with symptomatic cervical disc disease (SCDD). Methods: This multicentre, prospective, randomized controlled trial was initiated after ethics committee approval at nine centres (China/Hong Kong/Korea/Singapore/Taiwan). Patients with single-level SCDD involving C3-C7-vertebral segments were randomized (2:1) into: group-A treated with ProDisc–C and group-B with ACDF. Assessments were conducted at baseline, 6-weeks, 3/6/12/18/24-months post-surgery and annually thereafter till 84-months. Primary endpoint was overall success at 24-months, defined as composite of: (1) ≥ 20% improvement in neck disability index (NDI); (2) maintained/improved neurologic parameters; (3) no implant removal/revision/re-operation at index level; and (4) no adverse/severe/life-threatening events. Results: Of 120 patients (80ProDisc–C,40ACDF), 76 and 37 were treated as per protocol (PP). Overall success (PP) was 76.5% in group-A and 81.8% in group-B at 24-months (p = 0.12), indicating no clear non-inferiority of ProDisc-C to ACDF. Secondary outcomes improved for both groups with no significant inter-group differences. Occurrence of ASD was higher in group-B with no significant between-group differences. Range of motion (ROM) was sustained with ProDisc–C but lost with ACDF at 24-months. Conclusion: Cervical TDR with ProDisc–C is feasible, safe, and effective for treatment of SCDD in Asians. No clear non-inferiority was demonstrated between ProDisc-C and ACDF. However, patients treated with ProDisc–C demonstrated significant improvement in NDI, neurologic success, pain scores, and 36-item-short-form survey, along with ROM preservation at 24-months. Enrolment difficulties resulted in inability to achieve pre-planned sample size to prove non-inferiority. Future Asian-focused, large-scale studies are needed to establish unbiased efficacy of ProDisc-C to ACDF. [ABSTRACT FROM AUTHOR]

Study Design: Prospective cohort study.Objective: The aim of this article is to compare the mid- to long-term patient-reported outcome measures (PROMs) between single-level total disc arthroplasty (TDA), multi-level TDA, and hybrid constructs (combination of TDA and anterior lumbar interbody fusion [ALIF] across multiple levels) for symptomatic degenerative disc disease (DDD).Summary Of Background Data: The treatment of single-level DDD is well documented using TDA. However, there is still a paucity of published evidence regarding long-term outcomes on multi-level TDA and hybrid constructs for the treatment of multi-level DDD, as well as lack of long-term comparisons regarding treatment of single-level DDD and multi-level DDD.Methods: A total of 950 patients underwent surgery for single-level or multi-level DDD between July 1998 and February 2012 with single-level TDA (n = 211), multi-level TDA (n = 122), or hybrid construct (n = 617). Visual Analog Score for the back (VAS-B) and leg (VAS-L) were recorded, along with the Oswestry Disability Index (ODI) and Roland Morris Disability Questionnaire (RMDQ).Results: All PROMs in all groups showed statistically and clinically significant improvements (P < 0.005) in pain and function that is well above the corresponding minimum clinically important difference (MCID) and exceeds literature thresholds for substantial clinical benefit (SCB). Unadjusted analyses show that there were no statistically significant differences in the change scores between the surgery groups for VAS back and leg pain, and RMDQ up to 8 years' follow-up. Adjusted analyses showed the ODI improvement score for the single group was 2.2 points better (95% confidence interval [CI]: 0.6-3.9, P = 0.009) than in the hybrid group. The RMDQ change score was better in the hybrid group than in the multi-level group by 1.1 points (95% CI: 0.4-1.9, P = 0.003) at 6 months and a further 0.4 point at 2 years (95% CI: 0.1-0.8, P = 0.011).Conclusion: In the setting of meticulous preoperative evaluation in establishing a precision diagnosis, clinically and statistically equivalent results can be achieved when treating symptomatic DDD through single-level TDA, multi-level TDA, and hybrid constructs. These results are sustained at mid- to long-term follow-up.Level of Evidence: 3. [ABSTRACT FROM AUTHOR]

Background Context: Cervical total disc arthroplasty (TDA) is an alternative procedure to anterior cervical discectomy and fusion that facilitates neural decompression while both preserving motion of the spinal unit and decreasing the risk for degenerative changes at adjacent segments. However, due to its more recent introduction in clinical practice and low complication rates, the modes by which TDA may fail remain to be described.Purpose: This study sought to identify the modes and frequencies of cervical TDA failure in order to propose a novel classification system.Study Design: Retrospective cohort and systematic review.Patient Sample: Patients who underwent single or two-level TDA for cervical radiculopathy or myelopathy at a single institution and in the literature of medium and large prospective studies.Outcome Measures: Cervical TDA failure, defined as subsequent surgical intervention at the index segment.Methods: This study retrospectively reviewed patients who underwent single or two-level TDA for cervical radiculopathy or myelopathy at a single institution to identify the potential implant failure modes. A systematic review and meta-analysis of prospective data in the literature was then performed to further supplement failure mode identification and to describe the rates at which the various failure types occurred. Statistical analysis included between-group comparisons of Non-Failed and Failed patients and frequencies of each failure type among Failed patients.Results: A retrospective review at our institution of 169 patients (201 levels) identified eight failures, for a failure rate of 4.7%. Additionally, seven patients were revised who had the primary surgery at an outside institution. The systematic review of 3976 patients (4525 levels) identified 165 (4.1%) additional failures. Using this data, six primary failure types were classified, with several subtypes. These include recurrent or persistent index-level stenosis (Type I); migration (Type II) presenting as gross extrusion (A) or endplate failure with subsidence/acute fracture (B); instability (Type III) due to mechanical loosening (A), septic loosening (B), or device fracture (C); device motion loss (Type IV) such as "locking" of the device in kyphosis; implantation error (Type V) due to malposition (A) or improper sizing (B); and wear (Type VI) either without osteolysis (A) or with wear-particle-induced osteolysis (B). Stenosis (Type I) was the most common mode of failure found both through retrospective review and in the literature.Conclusions: Cervical TDA fails through six primary mechanisms. While rates of certain failures requiring subsequent surgical intervention are low, it is possible that these complications may become more prevalent upon further longitudinal observation. Thus, future application and validation of this classification system is warranted to evaluate how failure frequencies change over time and with larger patient samples. [ABSTRACT FROM AUTHOR]

Anterior cervical discectomy and fusion (ACDF) immobilizes surgical segments and can lead to the development of adjacent segment degeneration and adjacent segment disease. Thus, cervical total disc replacement (CTDR) has been developed with the aim to preserve the biomechanics of spine. However, heterotopic ossification (HO), a complication following CTDR, can reduce the segmental range of motion (ROM) and defects the motion-preservation benefit of CTDR. The pathological process of HO in CTDR remains unknown. HO has been suggested to be a self-defense mechanism in response to the non-physiological biomechanics of the cervical spine following CTDR. The current literature review is concerned with the association between the biomechanical factors and HO formation and the clinical significance of HO in CTDR. Endplate coverage, disc height, segmental angle, and center of rotation may be associated with the development of HO. The longer the follow-up, the higher the rate of ROM-limiting HO. Regardless of the loss of motion-preservation benefit of CTDR in patients with HO, CTDR confers patients with a motion-preservation period before the development of ROM-limiting HO. This may delay the development of adjacent segment degeneration compared with ACDF. Future clinical studies should explore the association between HO and changes in biomechanical factors of the cervical spine.

Abstract Background The effectiveness of lumbar total disc replacement (TDR) with different prostheses for sagittal alignment has been reported previously. However, there are only few reports on Activ L TDR and no specific evidence regarding whether sagittal alignment affects the clinical outcomes. Methods Eighty-seven patients who underwent mono- or bi-segmental lumbar TDR with Activ L were studied. The films of the upright anteroposterior and lateral spine in neutral, flexion, and extension positions were obtained before surgery and at 1 month and 1 and 3 years after surgery. The radiographic parameters such as lumbar lordosis (LL), index level lordosis (IL), pelvic incidence (PI), pelvic tilt (PT), segmental lordosis (SL), and sacral slope (SS) were measured based on the lateral upright radiographs. Clinical outcomes were evaluated using the Oswestry Disability Index (ODI) and visual analog scale (VAS) pre- and post-operatively. Results Eighty-seven patients with complete radiographic data were available for a 3-year follow-up period. Of these, 66 received a single-level TDR, and 21 received a 2-level TDR. At 1 month, the mean LL was similar to the pre-operative data and then was significantly increased to 45.1° at 3 years. On average, the IL tended to significantly increase, while the mean SL at L–5 was increased from 16.5° pre-operatively to 21.0° at 3 years. The mean SL at L1–2, L2–3, L3–4, and L5–S1; PI; PT; and SS showed no obvious difference after 3 years. In contrast, VAS and ODI scores showed significant improvement after surgery. Conclusions Activ L TDR showed a favorable effect on sagittal alignment, enhancing the IL while preserving the LL and SS. However, satisfactory clinical results for over a 3-year follow-up were not affected by sagittal alignment.

Abstract Background The principles of choosing an appropriate implant height remain controversial in total cervical disc replacement (TDR). By performing an in vitro biomechanical study and exploring the biomechanical impact of implant height on facet joint and motion function, the study aimed to offer valid proposals regarding implant height selection during TDR. Methods A total of 6 fresh-frozen male cadaveric cervical spines (C2–C7) with 5 mm intervertebral disc height at C5/6 level were enrolled in the study. Specimens with the intact condition and with different height artificial discs were tested. Facet joint pressures and range of motion under each condition were recorded using a specialized machine. Results The artificial disc heights that were involved in this study were 5 mm, 6 mm, and 7 mm. The range of motion decreased along with the increment of implant height, while facet joint pressure showed an opposite trend. Specimens with a 5 mm implant height could provide a similar range of motion (11.8° vs. 12.2° in flexion-extension, 8.7° vs. 9.0° in rotation, 7.9° vs. 8.2° in lateral bending) and facet joint pressure (27.8 psi vs. 25.2 psi in flexion, 59.7 psi vs. 58.9 psi in extension, 24.0 psi vs. 22.7 psi in rotation, 32.0 psi vs. 28.8 psi in lateral bending) compared with intact specimens. Facet joint pressure of specimens with 6 mm implant height (≥ 1 mm in height) increased during flexion at the C5–6 segment (30.4 psi vs. 25.2 psi, P = 0.076). However, specimens with 7 mm implant height (≥ 2 mm in height) showed a significant reduction in motion (9.5° vs. 12.2° in flexion-extension, P < 0.001) and increment of facet joint pressure at C5–6 segment (44.6 psi vs. 25.2 psi in flexion, 90.3 psi vs. 58.9 psi in extension, P < 0.0001) and adjacent segments. Conclusions This study suggested that an appropriate artificial disc height can achieve near-normal biomechanical properties and is recommended. We should be very cautious when using artificial discs ≥ 1 mm in height compared to normal. However, implants ≥ 2 mm in height compared to normal significantly increased the facet joint pressure and decreased the range of motion; therefore, it should not be used in clinical practice.

Background: Total disc replacement as a treatment for degenerative disc disease is gaining increased popularity. There is limited data in the literature about formation of a pseudotumor as a complication following this procedure. We report a very rare case of a pseudotumor after a lumbar total disc replacement with a review of the literature. Methods: A case study of a 49-year-old lady, who underwent L4-L5 total disc replacement and presented one year later with progressive back pain radiating to both lower extremities. Imaging revealed a soft tissue mass around the prosthesis. A review of the literature for similar cases has been done and reviewed. Results: Imaging revealed a soft tissue mass around the prosthesis and left hydronephrosis. CT venogram for leg swelling showed total occlusion of the left common iliac vein. CT myelogram showed compression of the cauda from the pseudotumor. The prosthesis was removed and replaced by an allograft fusion cage and plate. Intraoperatively both extremities became pulseless and bilateral common iliac arteries thrombectomy was carried out. This occurred again after closure immediately and bilaterally femoral artery exploration and thrombectomy was carried out. Histopathology showed a soft tissue with fibrinous necrosis and lymphohistiocytic inflammation. Conclusion: Soft tissue reaction and pseudotumor formation can be induced by Metal-on-Metal total disc replacement prostheses. Neurologic, vascular, and visceral complications may occur. In this case implant removal can stopped progression of the soft tissue reaction. Most patients in the literature benefit from implant removal followed by spinal fusion.

BackgroundThe cervical total disc replacement (cTDR) was developed to treat cervical degenerative disc disease while preserving motion.ObjectiveCost-effectiveness of this intervention was established by looking at 2-year follow-up, and this update reevaluates our analysis over 5 years.MethodsData were derived from a randomized trial of 330 patients. Data from the 12-Item Short Form Health Survey were transformed into utilities by using the SF-6D algorithm. Costs were calculated by extracting diagnosis-related group codes and then applying 2014 Medicare reimbursement rates. A Markov model evaluated quality-adjusted life years (QALYs) for both treatment groups. Univariate and multivariate sensitivity analyses were conducted to test the stability of the model. The model adopted both societal and health system perspectives and applied a 3% annual discount rate.ResultsThe cTDR costs $1687 more than anterior cervical discectomy and fusion (ACDF) over 5 years. In contrast, cTDR had $34 377 less productivity loss compared with ACDF. There was a significant difference in the return-to-work rate (81.6% compared with 65.4% for cTDR and ACDF, respectively; P = .029). From a societal perspective, the incremental cost-effective ratio (ICER) for cTDR was -$165 103 per QALY. From a health system perspective, the ICER for cTDR was $8518 per QALY. In the sensitivity analysis, the ICER for cTDR remained below the US willingness-to-pay threshold of $50 000 per QALY in all scenarios (-$225 816 per QALY to $22 071 per QALY).ConclusionThis study is the first to report the comparative cost-effectiveness of cTDR vs ACDF for 2-level degenerative disc disease at 5 years. The authors conclude that, because of the negative ICER, cTDR is the dominant modality.AbbreviationsACDF, anterior cervical discectomy and fusionAWP, average wholesale priceCE, cost-effectivenessCEA, cost-effectiveness analysisCPT, Current Procedural TerminologycTDR, cervical total disc replacementCUA, cost-utility analysisDDD, degenerative disc diseaseDRG, diagnosis-related groupFDA, US Food and Drug AdministrationICER, incremental cost-effectiveness ratioIDE, Investigational Device ExemptionNDI, neck disability indexQALY, quality-adjusted life yearsRCT, randomized controlled trialRTW, return-to-workSF-12, 12-Item Short Form Health SurveyVAS, visual analog scaleWTP, willingness-to-pay.

IntroductionThere is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C(®) with ACDF at 5-year follow-up.MethodsThis prospective, randomized, controlled trial was conducted as a Food and Drug Administration regulated Investigational Device Exemption trial across 23 centers with 245 patients randomized (2:1) to receive TDR with Mobi-C(®) Cervical Disc Prosthesis or ACDF with anterior plate and allograft. Outcome assessments included a composite overall success score, Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form-12 (SF-12) health survey, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent segment degeneration.ResultsThe 60-month follow-up rate was 85.5% for the TDR group and 78.9% for the ACDF group. The composite overall success was 61.9% with TDR vs. 52.2% with ACDF, demonstrating statistical non-inferiority. Improvements in NDI, VAS neck and arm pain, and SF-12 scores were similar between groups and were maintained from earlier follow-up through 60 months. There was no significant difference between TDR and ACDF in adverse events or major complications. Range of motion was maintained with TDR through 60 months. Device-related subsequent surgeries (TDR: 3.0%, ACDF: 11.1%, p

Introduction: Cervical total disc replacement (CTDR) is an alternative to anterior cervical discectomy and fusion for select patients that may preserve range of motion and reduce adjacent segment disease. Various CTDR prostheses are available; however, comparative data are limited. This study aimed to compare the short-term kinematic and radiological parameters of the M6-C, Mobi-C, and the CP-ESP prostheses. Methods: This retrospective cohort study included patients treated with CTDR between March 2005 and October 2020 at a single institution. Patients were included if their follow-up assessment included lateral erect and flexion/extension radiographs. The primary outcome assessed at 3-months postoperatively was range of motion, measured by the difference in functional spinal unit angle between flexion and extension. Results: A total of 131 CTDR levels (120 patients, 46.2 ± 10.1 years, 57% male) were included. Prostheses implanted included the M6-C (n = 52), Mobi-C (n = 54), and CP-ESP (n = 25). Range of motion varied significantly (8.2° ± 4.4° vs. 10.9° ± 4.7° vs. 6.1° ± 2.7°, P < 0.001). On post hoc analysis, the Mobi-C prosthesis demonstrated a significantly greater range of motion than either the M6-C prosthesis (P = 0.003) or CP-ESP (P < 0.001). Conclusion: Although the optimal range of motion for CTDR has not been established, short-term differences in the range of motion may guide the selection of CTDR prosthesis. Further studies with longer follow-up and consideration of clinical outcome measures are necessary. [ABSTRACT FROM AUTHOR]