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Background: Lumbar total disc replacement (TDR) is an alternative to lumbar fusion for the management of degenerative disc disease. This study aims to provide insight into the long-term clinical outcomes of lumbar TDR with a mean follow-up of 17.2 years in a group of workers' compensation patients., Methods: A total of 26 workers' compensation patients with radiographically confirmed discogenic low back pain were treated with the Charité total lumbar disc replacement. Visual analog scale (VAS) scores were assessed before and after the surgery. At follow-up, patients were assessed on quality of life, employment, further lumbar spine surgeries, and associated complications. Simple nonparametric statistical analysis was performed by the first author using Microsoft Excel., Results: Sixteen patients (62%) were able to be contacted with a mean follow-up time of 17.2 years. VAS scores at 17 years were significantly lower than their preoperation level. Of those 16 patients, 81% returned to work and worked for an average of 9.1 years after surgery. Additionally, 6 (38%) patients underwent further lumbar spinal surgery, of whom 4 underwent fusions of the adjacent segment. Nearly all patients (94%) were satisfied with the surgery., Conclusion: This study suggests lumbar TDR may be a useful treatment for degenerative disc disease in select workers' compensation patients., Clinical Relevance: Clinically relevant improvements in pain and employment can be achieved with the charite lumbar TDR in the treatment of degenerative disc disease in workers' compensation patients. These results are sustained over the long term., Competing Interests: Declaration of Conflicting Interests: The authors report no conflicts of interest in this work., (This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2022 ISASS. To see more or order reprints or permissions, see http://ijssurgery.com.)

Background: Total disc replacement (TDR) has been shown to be effective for the treatment of lumbar degenerative disc disease (DDD) in carefully selected patients. Previous studies have demonstrated high rates of patient satisfaction and improvement in patient-reported outcome measures (PROMs) compared with preoperative status but most have short-term follow-up or small cohort sizes only., Objective: The aim of this study is to report mid- to long-term PROMs from the treatment of symptomatic single-level lumbar DDD with TDR., Methods: Data collected prospectively concerning single-level TDR performed via an anterior approach were included for analysis. A preoperative assessment was obtained followed by postoperative follow-up assessments at 3, 6, and 12 months, and yearly follow-up thereafter. PROMs included patient satisfaction, visual analog score back and leg, Oswestry Disability Index, and Roland-Morris Disability Questionnaire., Results: A total of 211 patients (118 men, 93 women) operated on between June 1997 and July 2015 were included in this study. Minimum follow-up was 4 years. The average age was 42.2 (range 24-87) years and median follow-up 96 interquartile range 72-132, range 48-120) months. The operative levels were L5-S1 (160, 75.8%) and L4-L5 (61, 24.2%). Both statistically and clinically significant improvements observed postoperatively were maintained at 10 years. In addition, 92% of patients reported either good ( n = 29) or excellent satisfaction ( n = 155) with treatment at final review., Conclusions: This study shows that single-level lumbar TDR used appropriately in selected patient results in clinically significant improvements in pain and function, well above the minimum clinically important difference, and good to excellent satisfaction in most patients. Further study to define long-term outcomes and survivorship is required., Clinical Relevance: Statistically significant and clinically relevant improvements can be achieved by single-level lumbar TDR, in the treatment of single-level discogenic axial low back pain, with or without radiculopathy. These outcomes are sustained in the mid- to long-term followup periods., Competing Interests: Declaration of Conflicting Interests: Matthew Scott-Young previously received royalties and had a consulting agreement with DePuy Synthes Spine. The remaining authors have no disclosures., (This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2022 ISASS. To see more or order reprints or permissions, see http://ijssurgery.com.)

Background: Anterior approaches to surgically access the lumbar intervertebral discs are associated with a risk of developing major vascular injury and bleeding. The likelihood of injury increases in the presence of dense adherence between the disc annulus, vertebral periosteum, and vessels, which result from reactive inflammatory changes that cause fibrous scarring., Objective: To identify factors that predict vascular adherence, which may facilitate preoperative planning and technique modifications for anterior spine surgery., Study Design: Prospective study examining patients undergoing anterior retroperitoneal exposure for lumbar disc surgery., Methods: A total of 246 consecutive patients were enrolled in this study, all of whom had anterior retroperitoneal exposure for lumbar disc surgery. Patient demographics, smoking status, magnetic resonance imaging (MRI) findings, operative parameters, and dissection difficulty associated with vascular adherence were recorded. Current smokers were defined as those who smoked at the time of surgery or had ceased smoking <6 months before the operation. Patients were excluded if they were morbidly obese or had previously undergone anterior spine surgery or radiotherapy., Results: A multivariate regression analysis identified 2 significant risk factors for difficult dissections that are complicated by vascular adhesion: Modic Type 2 changes on MRI ( P = 0.009) and any history of smoking ( P = 0.007). Patients with Modic Type 2 changes or a smoking history were 2.1 and 2.2 times more likely to present with vascular adherence, respectively., Conclusions: Modic Type 2 changes on MRI and any smoking history can predict the adherence of large blood vessels to the anterior disc annulus, which enhances the difficulty of the dissection. These predictors could indicate to spinal surgeons that the patient has a 2-fold increased risk of vascular adherence., Clinical Relevance: Modic Type 2 changes on MRI and any smoking history can predict the adherence of large blood vessels to the anterior disc annulus, which enhances the difficulty of the dissection. These predictors could indicate to spinal surgeons that the patient has a 2-fold increased risk of vascular adherence during anterior lumbar exposure., Level of Evidence: 3., Competing Interests: Declaration of Conflicting Interests: Greg Malham: Globus (consultant), Device Technologies (travel), LifeHeathcare (travel). Nicholas Johnson: None. Matthew Claydon: Globus (consultant)., (This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2021 ISASS. To see more or order reprints or permissions, see http://ijssurgery.com.)

Background: This study compared 7-year safety and efficacy outcomes of activL and ProDisc-L lumbar total disc replacements in patients with symptomatic, single-level lumbar degenerative disc disease (DDD). The objectives are to report 7-year outcomes of the trial, evaluate the outcomes for patients lost to follow-up, and determine whether early outcomes predict long-term outcomes., Methods: This was a prospective, multicenter, randomized, controlled investigational device exemption study. Eligible patients with symptomatic, single-level lumbar DDD had failed ≥6 months of nonsurgical management. Patients ( N = 283) were randomized to receive activL ( n = 218) or ProDisc-L ( n = 65). At 7 years, data were available from 206 patients (activL, 160; ProDisc-L, 46). Logistic regression models were fit to predict 7-year outcomes for patients lost to follow-up after 2 years., Results: At 7 years, the activL group was noninferior to the ProDisc-L group on the primary composite endpoint ( P = .0369). Both groups showed significant reductions in back/leg pain severity and improvements in disability index and quality-of-life relative to baseline ( P < .0001). In both groups, opioid use was significantly reduced at 7 years (0%) relative to baseline ( P < .01), and the overall reoperation rates were low (4.6%). activL patients showed a significantly better range of motion (ROM) for flexion-extension rotation than ProDisc-L patients ( P = .0334). A significantly higher proportion of activL patients did not report serious adverse events (activL, 62%; ProDisc-L, 43%; P = .011). Predictive modeling indicated that >70% of patients (depending on outcome) lost to follow-up after 2 years would show clinically significant improvement at 7 years if improvements were achieved at 2 years., Conclusions: The benefits of activL and ProDisc-L are maintained after 7 years, with significant improvements from baseline observed in pain, function, and opioid use. activL is more effective at preserving ROM than ProDisc-L and has a more favorable safety profile. Improvements in other primary and secondary outcomes were similar between both disc designs., Level of Evidence: 1., (This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2021 ISASS.)

Background: Cervical disc arthroplasty (CDA) is an established treatment for degenerative disc disease with radiculopathy and/or myelopathy. There is, however, little published evidence of its effectiveness to relieve pain and improve function in patients with a primary diagnosis of axial neck pain. Such patients were excluded from all previous Food and Drug Administration clinical trials for CDA. We compare the outcomes of patients who underwent CDA for 3 common cervical conditions from 2003 to 2018., Methods: Seven hundred and eighty-two CDA patients at a single site were grouped by primary diagnosis: predominant axial neck pain (ANP) (n = 257), predominant radiculopathy (RAD) (n = 331), or a combination of both (ANP + RAD) (n = 195). Mixed models for repeated measures predicted and analyzed scores at all time points, adjusting for diagnosis group, time point, and, if statistically significant, number of operative levels and demographic characteristics. Outcome measures included the Neck Disability Index, numerical pain scales (intensity plus frequency), the Veterans RAND 12 Item Health Survey (VR-12) Physical Component Score, the Mental Component Score, and reoperations. Patients were assessed preoperatively and postoperatively at 6 weeks, 3 months, 6 months, 1 year, and annually thereafter., Results: At baseline, arm pain scores in the ANP group were statistically lower ( P = .0002) than in the RAD and ANP + RAD groups, consistent with preoperative diagnoses. Surgeries included 40.8% 1-level, 41.6% 2-level, 14.7% 3-level, and 2.9% 4-level. For all outcome measures, improvements were statistically significant from baseline to each postoperative time point without statistical difference between the 3 diagnosis groups. In total, 45/782 patients (5.8%) underwent a secondary surgery: 3.5% ANP, 5.8% RAD, and 8.7% ANP + RAD. Days to reoperation did not statistically differ between groups ( P = .489)., Conclusions: Appropriately selected patients with predominant axial neck pain treated with CDA may achieve clinical and functional outcomes comparable to patients with a primary diagnosis of radiculopathy or of axial neck pain with concomitant radiculopathy., Clinical Relevance: This study provides information that should help clinicians decide whether to offer CDA for patients with a primary diagnosis of axial neck pain and to appropriately counsel such patients about expected outcomes., Level of Evidence: 4., (This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2021 ISASS.)

Complications with cervical arthroplasty can be generalized to errors in patient selection or surgical technique. Patients with advanced spondylosis or osteophytic disease, severe facet arthropathy, osteoporosis, sagittal deformity, or preoperative instability are poor candidates for arthroplasty and are more prone to complications. Poor surgical technique can result in subsidence, expulsion, and kyphosis, and it can contribute to heterotopic ossification. Additionally, all of the inherent complications from an anterior cervical approach may occur with cervical artificial disc placement. This article will focus on the complications uniquely associated with cervical arthroplasty., (This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2020 ISASS.)

Activities of daily living require the subaxial cervical spine (C2-C7) to have substantial mobility. Cervical degenerative changes can cause abnormal motions and altered load distribution, leading to pain and limiting the ability of individuals to perform activities of daily living. Anterior cervical discectomy and fusion (ACDF) has been widely used to treat symptomatic cervical spondylosis. Clinical studies have shown cervical disc arthroplasty (CDA) to be a viable alternative to ACDF for the treatment of radiculopathy and myelopathy. The benefits of CDA are based on the premise that preservation of physiologic motions and load-sharing at the treated level would lead to longevity of the index-level facet joints and mitigate the risk of adjacent segment degeneration.This review article classifies cervical disc prostheses according to their kinematic degrees of freedom and device constraints. Discussion on how these design features may affect cervical motion after implantation will provide the reader with valuable information on how disc prostheses may function clinically.The ability of a disc prosthesis to work in concert with remaining bony and soft tissue structures to restore physiologic motion and load-sharing is a function of the following design features and surgical factors: Kinematic degrees of freedom-Prostheses that allow translation independent of rotation allow, in theory, the spinal anatomy to dictate segmental motion after CDA potentially restoring physiologic motion and load-sharing. A 6-degrees-of-freedom disc prosthesis may be best equipped to achieve the intended function of CDA.Built-in stiffness-A disc prosthesis with built-in resistance to angular and translational motion may have an advantage in restoring stability to a hypermobile segment without eliminating motion.Surgical factors related to prosthesis implantation may influence cervical segments after CDA. These factors include the amount of disc space distraction caused by the prosthesis, prosthesis placement in the sagittal and coronal planes, and integrity of the soft tissue envelope., (This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2020 ISASS.)

Background: Patient selection for cervical disc arthroplasty (CDA) in the United States remains a topic of debate among surgeons. Many surgeons base US patient selection for CDA implantation on the Food and Drug Administration (FDA) indications/contraindications. While off-label use does occur, the frequency and extent of off-label use in the US remains largely unknown. Outside the United States, patient selection is notably less stringent; however such data also remain largely unpublished or presented/published with a low level of evidence. Here, we will review the current approved US on-label patient selection criteria for CDA and discuss the rationale and supporting evidence to expand these criteria in the United States., Methods: A PubMed literature search was completed using the keywords "cervical disc arthroplasty" and "cervical disc replacement." The articles were evaluated by the authors for patient selection criteria., Conclusions: The current published data do not conclusively prove that the patients excluded from CDA by strict adherence to FDA indications would benefit from CDA surgery over anterior cervical discectomy and fusion. As surgeons, it is a difficult decision regarding when to expand indications to include off-label use of CDA. In our practice, generally CDA patient selection agrees with the FDA indications and contraindications, as there is a lack of level 1 evidence to confirm effectiveness of CDA outside of the current FDA indications. We will likely need more well-constructed studies to include prospective and controlled trials that specifically evaluate the "off-label" applications before US surgeons are convinced to expand indications and insurance companies agree to reimburse., (This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2020 ISASS.)

Objectives: This was an analytic retrospective observational study. The aims were (1) to validate patient-specific templating process by comparing postoperative range of motion (ROM) with that predicted by the model, (2) to retrospectively determine the ideal implant size, height, configuration, and location to evaluate if the ROM achieved could have been improved, and (3) to correlate postoperative ROM and clinical outcome., Background: Previous research revealed that after total disc replacement surgery, 34% of patients with less than 5° of postoperative ROM developed adjacent segment disease. The match between patient anatomy (size, facet orientation, disc height) and implant parameters are likely to affect postoperative ROM and clinical outcomes., Methods: Seventeen consecutive patients were implanted with 22 ProDisc-L devices between 2008 and 2015. Three-dimensional finite element (FE) models of the implanted segment were constructed from preoperative computed tomography scans and virtually implanted with the ProDisc-L implant. ROM was determined with the endpoints of facet impingement in flexion and implant contact in extension. FE templating was used to determine the optimal implant size and location. ROM was then measured directly from flexion and extension radiographs and compared to predicted ROM. Pre and postoperative Oswestry Disability Index (ODI) data were used to correlate ROM with clinical outcomes., Results: No significant difference was found between the actual and predicted ROM. The computational templating procedure identified an optimal ROM that was significantly greater than actual ROM. The ROM in our cohort could have been improved by an average of 1.2° or 12% had a different implant size or position been used., Conclusions: FE analyses accurately predicted ROM in this cohort and can facilitate selection of the optimal implant size and location that we believe will increase the chance of achieving clinical success with the application of this technology., Competing Interests: Disclosures and COI: Part funding for this project was provided through a research grant from the Anschutz Foundation. The authors have no relevant conflicts of interest.

Background: Outpatient surgery has been shown safe and effective for anterior cervical discectomy and fusion (ACDF), and more recently, for 1-level cervical disc arthroplasty (CDA). The purpose of this analysis is to compare the safety and efficiency of 1-level and 2-level CDA performed in an ambulatory surgery center (ASC) and in a hospital setting., Methods: The study was a retrospective collection and analysis of data from consecutive CDA patients treated in ASCs compared to a historical control group of patients treated in hospital settings who were classified as outpatient (0 or 1-night stay) or inpatient (2 or more nights). Surgery time, blood loss, return to work, adverse events (AEs), and subsequent surgeries were compared., Results: The sample consisted of 145 ASC patients, 348 hospital outpatients, and 65 hospital inpatients. A greater proportion of 2-level surgeries were performed in hospital than ASC. Surgery times were significantly shorter in ASCs than outpatient or inpatient 1-level (63.6 ± 21.6, 86.5 ± 35.8, and 116.7 ± 48.4 minutes, respectively) and 2-level (92.4 ± 37.3, 126.7 ± 43.8, and 140.3 ± 54.5 minutes, respectively) surgeries. Estimated blood loss was also significantly less in ASC than outpatient and inpatient 1-level (18.5 ± 30.6, 43.7 ± 35.9, and 85.7 ± 98.0 mL, respectively) and 2-level (21.1 ± 12.3, 67.8 ± 94.9, and 64.9 ± 66.1 mL). There were no hospital admissions and no subsequent surgeries among ASC patients. ASC patients had 1 AE (0.7%) and hospital patients had 10 AEs (2.4%). Working patients returned to work after a similar number of days off, but fewer ASC patients had returned to work by the end of the 90-day period., Conclusions: Both 1- and 2-level CDA may be performed safely in an ASC. Surgeries in ASCs are of shorter duration and performed with less blood loss without increased AEs., Competing Interests: Disclosures and COI: The device manufacturer, Zimmer Biomet (formerly LDR Spine), sponsored the Mobi-C Cervical Disc ASC Study. Zimmer Biomet contributed to the design and conduct of the study, and provided assistance with analysis of data and manuscript review. The authors also report receiving writing or editorial assistance for this paper from Zimmer Biomet. These authors report the following potential or perceived conflicts: M.F. Gornet reports consulting for Aesculap and Medtronic; stockownership of Bonovo, International Spine & Orthopedic Institute, LLC, Nocimed, OuroBoros, Paradigm Spine; and royalties from Medtronic and RTI. R. Kube reports research support from Zimmer Biomet and consulting for Paradigm Spine. R. Sherban reports consulting for Zimmer Biomet. N.J. Wills reports consulting for Zimmer Biomet and Medtronic. F.W. Schranck reports stockownership: Nocimed.

Background: This research was initiated to compare the long-term clinical safety and effectiveness of the selectively constrained SECURE-C (Globus Medical, Audubon, Pennsylvania) Cervical Artificial Disc to anterior cervical discectomy and fusion (ACDF). To preserve segmental motion, cervical total disc replacement (CTDR) was developed as an alternative to ACDF. Current CTDR designs incorporate constrained and unconstrained metal-on-metal or metal-on-polymer articulation with various means of fixation., Methods: Eighteen investigational sites participated in this prospective clinical trial; 380 patients were enrolled and treated in the investigational device exemption study. The first 5 patients treated at each site were nonrandomized and received the investigational SECURE-C device. Patients were randomized, treated surgically, and evaluated postoperatively at 6 weeks, 3 months, 6 months, 12 months, 24 months, and annually thereafter through 84 months postoperative., Results: Overall results for the randomized cohorts demonstrated statistical superiority of the investigational SECURE-C group over the control ACDF group at 84 months postoperative. SECURE-C showed clinically significant improvement in pain and function in terms of neck disability index and visual analog scale scores, and superiority in patient satisfaction was also achieved for patients treated with SECURE-C., Conclusion: Clinical study results indicated that the selectively constrained SECURE-C Cervical Artificial Disc is as safe and effective as ACDF. Long-term results from the Post Approval Study demonstrated that SECURE-C is statistically superior to ACDF in terms of overall success and patient satisfaction. Lower rates of subsequent index-level surgeries and device-related adverse events were observed in the SECURE-C group than in the ACDF group. The long-term, level 1 clinical evidence presented here is consistent with other reports supporting the safety and efficacy of cervical arthroplasty, and furthers advocacy for motion preservation as a viable alternative to fusion.

Introduction: There 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., Methods: This 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., Results: The 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<0.02) and adjacent segment degeneration at the superior level (TDR: 37.1%, ACDF: 54.7%, p<0.03) were significantly lower for TDR patients., Conclusions: Five-year results demonstrate the safety and efficacy of TDR with the Mobi-C as a viable alternative to ACDF with the potential advantage of lower rates of reoperation and adjacent segment degeneration, in the treatment of one-level symptomatic cervical degenerative disc disease., Clinical Relevance: This prospective, randomized study with 5-year follow-up adds to the existing literature indicating that cervical TDR is a viable alternative to ACDF in appropriately selected patients., Level of Evidence: This is a Level I study.

Background: Fusion surgery in the rare patients suffering from symptomatic degenerative disc disease (DDD) at three segments has been reported to produce poor results and a high frequency of complications, why patients suffering from DDD at three segments are seldom offered surgical treatment., Purpose: To compare clinical outcome after one- and two years, between patients that have undergone disc replacement surgery (TDR) at three segments and patients that have been treated at less segments., Methods: The present study is based on data recorded in the Swedish Spine Registry (SweSpine). The study group consisted of 30 patients who underwent three-segment TDR, the comparative group of 700 patients treated in one or two segments. Analyses included comparisons of preoperative data, postoperative results and improvement from baseline., Results: Our results showed no differences in outcome between groups at one- and two years postoperatively. Improvements achieved after surgery in both groups well exceeded established values for minimally clinically important difference (MCID)., Conclusions: The results of this study show that patients with a diagnosis of therapy-resistant chronic low back pain (CLBP) due to DDD in one, two or even three lumbar segments achieve similar and good results after TDR surgery., Clinical Relevance: The rare patients with severe and convincing DDD from three segments might in carefully selected cases be offered surgery, with a reasonable chance of a beneficial outcome.

Background: Low back pain is one of the most prevalent problems in industrialized countries, affecting as many as 80% of all adults at some time in their lives. Among the significant contributors to low back pain is degenerative disc disease (DDD). Although fusion has been well accepted for treatment of DDD, high rates of complications and stress to adjacent segments remain a concern. Lumbar total disc replacement (TDR) was developed with a goal of preserving motion and avoiding various fusion-related complications, but the relative merits of single vs. multiple level arthroplasty remain unclear., Methods: This is a multi-center, single arm, prospective post-market registry of the M6-L, consisting of consecutive patients presenting with lumbar DDD who agreed to participate. This paper reports on those patients who have completed at least 24 months of followup to date. Clinical outcome measures include the Oswestry Disability Index (ODI) and back and leg Visual Analogue Scales (VAS). Radiographic analysis of disc angle and range of motion (ROM) was also performed., Results: Results for 83 patients comprising 121 implants in two cohorts (49 single level (SL), 34 multiple levels (ML)) are reported. Both cohorts experienced significant improvement at 24 months including significant decreases in ODI and VAS. Relative to SL procedures, ML procedures demonstrated either comparable results, or results that trended favorably towards the ML procedures. Index and global ROM at 24 months were not significantly different between the two cohorts, while the disc angles were larger in the SL cohort regardless of index level., Conclusions: This is the first study to report clinical and radiographic outcomes of TDR with the M6-L in SL vs ML procedures with two years of followup. The results suggest initial device safety and effectiveness when used for the treatment of lumbar degenerative disc disease at one or more levels.

Background: Mechanically replacing one or more pain generating articulations in the functional spinal unit (FSU) may be a motion preservation alternative to arthrodesis at the affected level. Baseline biomechanical data elucidating the quantity and quality of motion in such arthroplasty constructs is non-existent., Purpose: The purpose of the study was to quantify the motion-preserving effect of a posterior total disc replacement (PDR) combined with a unilateral facet replacement (FR) system at a single lumbar level (L4-L5). We hypothesized that reinforcement of the FSU with unilateral FR to replace the resected, native facet joint following PDR implantation would restore quality and quantity of motion and additionally not change biomechanics at the adjacent levels., Study Design: In-vitro study using human cadaveric lumbar spines., Methods: Six (n = 6) cadaveric lumbar spines (L1-S1) were evaluated using a pure-moment stability testing protocol (±7.5 Nm) in flexion-extension (F/E), lateral bending (LB) and axial rotation (AR). Each specimen was tested in: (1) intact; (2) unilateral FR; and (3) unilateral FR + PDR conditions. Index and adjacent level ROM (using hybrid protocol) were determined opto-electronically. Interpedicular travel (IPT) and instantaneous center of rotation (ICR) at the index level were radiographically determined for each condition. ROM, ICR, and IPT measurements were compared (repeated measures ANOVA) between the three conditions., Results: Compared to the intact spine, no significant changes in F/E, LB or AR ROM were identified as a result of unilateral FR or unilateral FR + PDR. No significant changes in adjacent L3-L4 or L5-S1 ROM were identified in any loading mode. No significant differences in IPT were identified between the three test conditions in F/E, LB or AR at the L4-L5 level. The ICRs qualitatively were similar for the intact and unilateral FR conditions and appeared to follow placement (along the anterior-posterior (AP) direction) of the PDR in the disc space., Conclusion: Biomechanically, quantity and quality of motion are maintained with combined unilateral FR + PDR at a single lumbar spinal level.

Background: Anterior cervical discectomy and fusion (ACDF) is the gold standard for treating symptomatic cervical disc degeneration. Cervical total disc replacements (TDRs) have emerged as an alternative for some patients. The purpose of this study was to evaluate the safety and effectiveness of a new TDR device compared with ACDF for treating single-level cervical disc degeneration., Methods: This was a prospective, randomized, controlled, multicenter Food and Drug Administration (FDA) regulated Investigational Device Exemption (IDE) study. A total of 245 patients were treated (164 TDR: 81 ACDF). The primary outcome measure was overall success based on improvement in Neck Disability Index (NDI), no subsequent surgical interventions, and no adverse events (AEs) classified as major complications. Secondary outcome measures included SF-12, visual analog scale (VAS) assessing neck and arm pain, patient satisfaction, radiographic range of motion, and adjacent level degeneration. Patients were evaluated preoperatively and postoperatively at 6 weeks, 3, 6, 12, 18, and 24 months. The hypothesis was that the TDR success rate was non-inferior to ACDF at 24 months., Results: Overall success rates were 73.6% for TDR and 65.3% for ACDF, confirming non-inferiority (p < 0.0025). TDR demonstrated earlier improvements with significant differences in NDI scores at 6 weeks and 3 months, and VAS neck pain and SF-12 PCS scores at 6 weeks (p<0.05). Operative level range of motion in the TDR group was maintained throughout follow-up. Radiographic evidence of inferior adjacent segment degeneration was significantly greater with ACDF at 12 and 24 months (p < 0.05). AE rates were similar., Conclusions: Mobi-C TDR is a safe and effective treatment for single-level disc degeneration, producing outcomes similar to ACDF with less adjacent segment degeneration., Level of Evidence: Level I., Clinical Relevance: This study adds to the literature supporting cervical TDR as a viable option to ACDF in appropriately selected patients with disc degeneration.

Background: The clinical success of cervical arthroplasty hinges on the ability to preserve or improve the biomechanics of the functional spinal unit. The purpose of this study was to conduct a radiologic assessment of kinematic parameters preimplantation and postimplantation of the PRESTIGE LP Cervical Disc System (Medtronic, Memphis, Tennessee)., Methods: A total of 120 radiographs of 20 patients following single-level implantation of the PRESTIGE LP were retrospectively reviewed. Static and dynamic radiologic assessments were performed before surgery and at 1 year postoperation. Kinematic parameters including range of motion (ROM), horizontal translation, center of rotation (COR X, Y), anterior disc height and posterior disc height, and disc angle and shell angle were assessed for each spinal level using quantitative motion analysis software. Clinical outcomes were assessed using the short form health survey physical component scores and mental component scores., Results: The mean physical component scores and mental component scores of the short form health survey (SF-36) improved significantly following surgery. At 1 year postoperation, ROM, translation, and COR X were preserved. The COR Y shifted superiorly from 3.17 ± 2.08 mm preoperation to 0.98 ± 2.23 mm postoperation (P < .001). The anterior disc height and posterior disc height were significantly increased following surgery (3.97 ± 1.01 to 4.78 ± 1.11 mm and 3.04 ± 0.69 to 3.66 ± 0.61 mm, respectively; P < .01). The preoperative disc angle was 3.32° ± 2.92° and the postoperative shell angle was 1.11° ± 4.29°, with a mean change of -2.22° ± 4.63° (P < .05)., Conclusions: The PRESTIGE LP maintained preoperative ROM, translation, and COR X values. The postoperative COR Y value changed significantly by shifting superiorly, accompanied by an increase in DH. There was a loss of lordosis at the level of surgery, with the PRESTIGE LP endplates having an almost parallel endplate configuration.

Background: Prior studies of multilevel ProDisc-L (PD-L) implants (Synthes Spine, Inc., West Chester, Pennsylvania) using the standard US technique have used conventional radiography postoperatively. We found vertebral body-splitting fractures (VB-SFs) in interposed vertebral bodies after 5 sequential multilevel PD-L device implantations using the standard US technique. These were identified with postoperative computed tomography (CT) but were not visible on plain radiographs. In an additional patient, we found that a stress-relieving, pilot holes-only technique did not prevent VB-SFs. The 5 patients operated on with the standard technique composed the background series against which we compared the incidence of VB-SFs in patients operated on with a modification of the standard US technique-a combination of stress-relieving pilot holes, removal of cortex in the chisel path, and a fenestrated chisel (PH/CR/FC)-intended to reduce the incidence of VB-SFs in multilevel PD-L constructs., Methods: Patients receiving multilevel PD-L implants at 2 sites-1 in the United States and the other in Germany-were operated on with the PH/CR/FC technique and their postoperative CT scans evaluated for the presence of VB-SFs. The frequency of VB-SFs in these patients was compared with that of the 5 patients from the background series who were operated on by the standard US technique. The groups' mean sex, age, body mass index, and vertebral body height, as well as average spinal T score, were also compared., Results: No fractures were found in 13 interposed vertebral bodies in 11 patients operated on with the PH/CR/FC technique, as compared with 4 VB-SFs and 1 anterior keel cut-to-anterior keel cut fracture in 5 interposed vertebral bodies in 5 patients operated on with the US technique (P ≤ .001). Although the sample sizes were small, this difference in fracture rate was not associated with sex, age, body mass index, or average spinal T score. At up to 13 months of follow-up of patients in the background series, we found that VB-SFs tend not to bridge with bone, instead forming sclerotic margins., Conclusions: The PH/CR/FC technique studied reduced the incidence of VB-SF in multilevel PD-L implants. Because previously published multilevel studies did not use postoperative CT scans and because VB-SFs are not visible on conventional radiography, the incidence of VB-SFs in multilevel PD-L applications may be higher than previously reported. Our findings may contribute to prevention of complications in total disc replacement.

Background: Cervical disc arthroplasty is regarded as a promising treatment for myelopathy and radiculopathy as an alternative to cervical spine fusion. On the basis of 2-year clinical data for the PRESTIGE(®) Cervical Disc (Medtronic, Memphis, Tennessee), the Food and Drug Administration recommended conditional approval in September 2006 and final approval in July 2007; however, relatively little is known about its wear and damage modes in vivo. The main objective was to analyze the tribological findings of the PRESTIGE(®) Cervical Disc. This study characterized the in vivo wear patterns of retrieved cervical discs and tested the hypothesis that the total disc replacements exhibited similar surface morphology and wear patterns in vitro as in vivo., Methods: Ten explanted total disc replacements (PRESTIGE(®), PRESTIGE(®) I, and PRESTIGE(®) II) from 10 patients retrieved after a mean of 1.8 years (range, 0.3-4.1 years) were analyzed. Wear testing included coupled lateral bending ( ±4.7°) and axial rotation ( ±3.8°) with a 49 N axial load for 5 million cycles followed by 10 million cycles of flexion-extension ( ±9.7°) with 148 N. Implant surfaces were characterized by the use of white-light interferometry, scanning electron microscopy, and energy dispersive spectroscopy., Results: The explants generally exhibited a slightly discolored, elliptic wear region of varying dimension centered in the bearing center, with the long axis oriented in the medial-lateral direction. Abrasive wear was the dominant in vivo wear mechanism, with microscopic scratches generally oriented in the medial-lateral direction. Wear testing resulted in severe abrasive wear in a curvilinear fashion oriented primarily in the medial-lateral direction. All retrievals showed evidence of an abrasive wear mechanism., Conclusions: This study documented important similarity between the wear mechanisms of components tested in vitro and explanted PRESTIGE(®) Cervical Discs; however, the severity of wear was much greater during the in vitro test compared with the retrievals.

Background: Lumbar disc arthroplasty (total disc replacement [TDR]) outcomes have been evaluated using subjective, patient-reported measures of pain, health, and functional impairment. As a condition of TDR coverage, our institution's health plan required that objective physical performance data be collected. Thus our study was designed to explore (1) the feasibility of using preoperative and 1-year postoperative performance on functional capacity tasks as an outcome metric for TDR with ProDisc-L (PD-L) (Synthes Spine, West Chester, Pennsylvania), (2) the magnitude and significance of changes in preoperative and postoperative performance, and (3) whether changes noted in performance are reflected in the subjective measures., Methods: Seven adapted WorkWell tasks (physical capability assessment tool [PCAT]) (WorkWell Systems, Duluth, Minnesota) were performed preoperatively and 1 year postoperatively by 18 patients who received either single-level or 2-level PD-L implants. Demographic and medical data were reviewed., Results: The PCAT was implemented easily, and the tasks took approximately 30 minutes to complete. Percent improvement and preoperative and postoperative physical capability outcomes for each PCAT task are as follows: squat, 79% (10.7 ± 7.1 repetitions vs 19.2 ± 2.0 repetitions, P < .001); forward bend, 121% (110.2 ± 68.8 seconds vs 243.6 ± 77.2 seconds, P < .001); kneel, 92% (283.2 ± 173.2 seconds vs 544.7 ± 109.3 seconds, P < .001); floor-to-waist lift, 128% (16.1 ± 9.9 lb vs 36.7 ± 20.3 lb, P < .001); horizontal carry, 119% (19.7 ± 8.6 lb vs 43.2 ± 18.3 lb, P < .001); push, 32% (67.7 ± 19.2 lb vs 89.4 ± 24.4 lb, P < .001); and pull, 40% (57.6 ± 17.1 lb vs 80.9 ± 26.4 lb, P < .001). Visual analog scale scores for pain (5.1 ± 1.7 vs 1.4 ± 1.6, P < .001), Oswestry Disability Index scores (49.0% ± 13.2% vs 15.2% ± 14.3%, P < .001), and amount of narcotic use (26.1 ± 43.8 mg of morphine equivalent vs 1.9 ± 7.3 mg of morphine equivalent, P = .031) also improved. In single-level cases, comparison of L4-5 versus L5-S1 showed significant differences only with the forward bend task (P = .002)., Conclusions/clinical Relevance: The physical capability outcome may be a feasible outcome metric. PD-L implantation may result in substantial improvements in physical performance. Similar benefits shown in a larger series over a longer timeframe could have important implications for the long-term health, productivity, and cost of health care for this patient population.

Background: Total disc replacement (TDR) promises preservation of spine biomechanics in the treatment of degenerative disc disease but requires more careful device placement than tradition fusion and potentially has a more challenging learning curve., Methods: A cohort of 44 consecutive patients had 1-level lumbar disc replacement surgery at a single institution by a single surgeon. Patients were followed up clinically and radiographically for 24 months. Patients were divided into 2 groups of 22 sequential cases each. Clinically, preoperative and postoperative Oswestry Disability Index, visual analog scale, Short Form 12 (SF-12) Mental and Physical Components, and postoperative satisfaction were measured. Radiographically, preoperative and postoperative range of motion (ROM) dimensions, prosthesis deviation from the midline, and disc height were measured. TDR-related complications were noted. Logarithmic curve-fit regression analysis was used to assess the learning curve., Results: Operative time decreased as cases progressed, with an asymptote after 22 cases. The operative time for the later group was significantly lower (P < .0005), but hospital stay was significantly longer (P = .03). There was no significant difference in amount of blood loss (P = .10) or prosthesis midline deviation (P = .86). Clinically, there was no significant difference in postoperative scores between groups in Oswestry Disability Index (P = .63), visual analog scale (P = .45), SF-12 Mental Component (P = .66), SF-12 Physical Component (P = .75), or postoperative satisfaction (P = .92) at 24 months. Radiographically, there was no significant difference in improvement between groups in ROM (P = .67) or disc height (P = .87 for anterior and P = .13 for posterior) at 24 months. For both groups, there was significant improvement for all clinical outcomes and disc height over preoperative values. One patient in the later group had device failure with subluxation of the polyethylene, which required revision., Conclusions/level of Evidence: Early experience can quickly reduce operative time but does not affect clinical outcomes or ROM significantly (level IV case series)., Clinical Relevance: Lumbar TDR is a rapidly learnable technique in treatment of degenerative disc disease.

Background: Fusion has long been used for treating chronic back pain unresponsive to nonoperative care. However, potential development of adjacent segment degeneration resulting in reoperation is a concern. Total disc replacement (TDR) has been proposed as a method for addressing back pain and preventing or reducing adjacent segment degeneration. The purpose of the study was to determine the reoperation rate at the segment adjacent to a level implanted with a lumbar TDR and to analyze the pre-TDR condition of the adjacent segment., Methods: This study was based on a retrospective review of charts and radiographs from a consecutive series of 1000 TDR patients to identify those who underwent reoperation because of adjacent segment degeneration. Some of the patients were part of randomized studies comparing TDR with fusion. Adjacent segment reoperation data were also collected from 67 patients who were randomized to fusion in those studies. The condition of the adjacent segment before the index surgery was compared with its condition before reoperation based on radiographs, magnetic resonance imaging (MRI), and computed tomography., Results: Of the 1000 TDR patients, 20 (2.0%) underwent reoperation. The mean length of time from arthroplasty to reoperation was 28.3 months (range, 0.5-85 months). Of the adjacent segments evaluated on preoperative MRI, 38.8% were normal, 38.8% were moderately diseased, and 22.2% were classified as having severe degeneration. None of these levels had a different grading at the time of reoperation compared with the pre-TDR MRI study. Reoperation for adjacent segment degeneration was performed in 4.5% of the fusion patients., Conclusions: The 2.0% rate of adjacent segment degeneration resulting in reoperation in this study is similar to the 2.0% to 2.8% range in other studies and lower than the published rates of 7% to 18% after lumbar fusion. By carefully assessing the presence of pre-existing degenerative changes before performing arthroplasty, this rate may be reduced even more.

Background: The biomechanical behavior of total disc replacement (TDR) and anterior cervical discectomy and fusion (ACDF) incomplex multiplanar motion is incompletely understood. The purpose of this study was to determine whether ACDF or TDR significantly affects in vitro kinematics through a range of complex, multiplanar motions., Methods: Seven human cervical spines from C4-7 were used for this study. Intact cervical motion segments with and without implanted TDR and ACDF were tested by use of unconstrained pure bending moment testing fixtures in 7 mechanical modes: axial rotation (AR); flexion/extension (FE); lateral bending (LB); combined FE and LB; combined FE and AR; combined LB and AR; and combined FE, LB, and AR. Statistical testing was performed to determine whether differences existed in range of motion (ROM) and stiffness among spinal segments and treatment groups for each mechanical test mode., Results: ACDF specimens showed increased stiffness compared with the intact and TDR specimens (P < .001); stiffness was not found to be different between TDR and intact specimens. ACDF specimens showed decreased ROM in all directions compared with TDR and intact specimens at the treated level. For the coupled motion test, including AR, LB, and FE, the cranial adjacent level (C4/C5) for the intact specimens (2.7°) showed significantly less motion compared with both the TDR (6.1°, P = .009) and ACDF (6.8°, P = .002) treatment groups about the LB axis. Testing of the C4/C5 and C6/C7 levels in all other test modes yielded no significant differences in ROM comparisons, although a trend toward increasing ROM in adjacent levels in ACDF specimens compared with intact and TDR specimens was observed., Conclusions: This study compared multiplanar motion under load-displacement testing of subaxial cervical motion segments with and without implanted TDR and ACDF. We found a trend toward increased motion in adjacent levels in ACDF specimens compared with TDR specimens. Biomechanical multiplanar motion testing will be useful in the ongoing development and evaluation of spinal motion-preserving implants.

Background: Current total disc replacement (TDR) for lumbar spine requires an anterior approach for implantation but presents inherent limitations, including risks to the abdominal structures, as well as resection of the anterior longitudinal ligament. By approaching the spine laterally, it is possible to preserve the stabilizing ligaments, which are a natural restraint to excessive rotations and translations, and thereby help to minimize facet stresses. This less invasive approach also offers a biomechanical advantage of placement of the device over the ring apophysis bilaterally; importantly, it also offers a greater opportunity for safer revision surgery, if necessary, by avoiding scarring of the anterior vasculature. We present the clinical and radiologic results of a lateral TDR device from a prospective single-center study., Methods: A new metal-on-metal TDR device designed for implantation through a true lateral, retroperitoneal, transpsoatic approach (extreme lateral interbody fusion) was implanted in 36 patients with discography-confirmed 1- or 2-level degenerative disc disease. Clinical (pain and function) and radiographic (range of motion) outcome assessments were prospectively collected preoperatively, postoperatively, and serially up to a minimum of 36 months' follow-up., Results: Between December 2005 and December 2006, 36 surgeries were performed in 16 men and 20 women (mean age, 42.6 years). These included 15 single-level TDR procedures at L3-4 or L4-5, 3 2-level TDR procedures spanning L3-4 and L4-5, and 18 hybrid procedures (anterior lumbar interbody fusion) at L5-S1 and TDR at L4-5 (17) or L3-4 (1). Operative time averaged 130 minutes, with mean blood loss of 60 mL and no intraoperative complications. Postoperative X-rays showed good device placement, with restoration of disc height, foraminal volume, and sagittal balance. All patients were up and walking within 12 hours of surgery, and all but 9 were discharged the next day (7 of those 9 were hybrid TDR-anterior lumbar interbody fusion cases). Postoperatively, 5 of 36 patients (13.8%) had psoas weakness and 3 of 36 (8.3%) had anterior thigh numbness, with both symptoms resolving within 2 weeks. Of the 36 patients, 4 (11%) had postoperative facet joint pain, all in hybrid cases. Visual analog scale pain scores and Oswestry Disability Index scores improved by 74.5% and 69.2%, respectively, from preoperatively to 3-year follow-up. Range of motion at 3 years postoperatively averaged 8.1°. Signals of heterotopic ossification were present in 5 patients (13.9%), and 2 patients (5.5%) were considered to have fusion after 36 months., Conclusions: The clinical and radiographic results of a laterally placed TDR have shown maintenance of pain relief and functional improvement over a long-term follow-up period. The benefits of the lateral access-minimal morbidity, avoidance of mobilization of the great vessels, preservation of the anterior longitudinal ligament, biomechanically stable orientation, and broader revision options-promote a new option for motion-preservation procedures.