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It is a controversial issue that the difference of the occurrence of heterotopic ossification (HO) concerning cervical prosthesis is still huge. In this study, in the two cervical disc prostheses the development of HO is independent on their architecture., Study Design. Retrospective analysis using data from randomized clinical trials. Objective. To compare the occurrence of heterotopic ossification (HO) between two cervical disc prostheses. Clinical outcome and range of motion (ROM) were also evaluated. Summary of Background Data. Cervical arthroplasty was reported to be able to maintain the segmental ROM. However, controversy exists since the difference of the occurrence of HO concerning cervical prosthesis is still huge. Methods. Patients who underwent anterior cervical discectomy with arthroplasty for a cervical radiculopathy due to a herniated disc from the The Netherlands Cervical Kinematics (NECK) trial (activC; metal endplates with a polyethylene inlay and a keel for primary stability) and the PROCON trial (Bryan; metal-on-polymer with titanium coated endplates without a keel) were analyzed for HO at 12 and 24 months postoperatively. HO was scored according to the McAfee–Mehren classification. Segmental ROM was defined by a custom developed image analysis tool, and global cervical ROM was measured by Cobb's angle. Clinical outcome was evaluated by means of the neck disability index (NDI) as well as physical-component summary (PCS) and mental-component summary (MCS). Results. At 2-year follow-up, the occurrence of HO was 68% in patients treated with the activC prosthesis (severe HO 55%), which was comparable with 85% (P = 0.12) in patients with the Bryan disc (severe HO 44%; P = 0.43). The HO progression was similar between groups. Clinically, the patients had comparable NDI, PCS, and MCS at 2-year follow-up, and comparable improvement of clinical outcomes. The global ROM in the Bryan group (56.4 ± 10.8°) was significantly higher than in the activC group (49.5 ± 14.0, P = 0.044) at 2-year follow-up. Conclusion. In comparison of two cervical disc prostheses the development of HO is independent on their architecture. Although global ROM was higher in the Bryan prosthesis group, this difference was not deemed clinically important, particularly because the clinical condition of patients with and without severe HO was comparable. Level of Evidence: 2

Aims The aim of this study was to investigate whether the type of cervical disc herniation influences the severity of symptoms at the time of presentation, and the outcome after surgical treatment. Methods The type and extent of disc herniation at the time of presentation in 108 patients who underwent anterior discectomy for cervical radiculopathy were analyzed on MRI, using a four-point scale. These were dichotomized into disc bulge and disc herniation groups. Clinical outcomes were evaluated using the Neck Disability Index (NDI), 36-Item Short Form Survey (SF-36), and a visual analogue scale (VAS) for pain in the neck and arm at baseline and two years postoperatively. The perceived recovery was also assessed at this time. Results At baseline, 46 patients had a disc bulge and 62 had a herniation. There was no significant difference in the mean NDI and SF-36 between the two groups at baseline. Those in the disc bulge group had a mean NDI of 44.6 (SD 15.2) compared with 43.8 (SD 16.0) in the herniation group (p = 0.799), and a mean SF-36 of 59.2 (SD 6.9) compared with 59.4 (SD 7.7) (p = 0.895). Likewise, there was no significant difference in the incidence of disabling arm pain in the disc bulge and herniation groups (84% vs 73%; p = 0.163), and no significant difference in the incidence of disabling neck pain in the two groups (70.5% (n = 31) vs 63% (n = 39); p = 0.491). At two years after surgery, no significant difference was found in any of the clinical parameters between the two groups. Conclusion In patients with cervical radiculopathy, the type and extent of disc herniation measured on MRI prior to surgery correlated neither to the severity of the symptoms at presentation, nor to clinical outcomes at two years postoperatively. Cite this article: Bone Joint J 2022;104-B(11):1242–1248.

Study Design: Randomized controlled trial. Objectives: Lumbar interbody fusion with cages is performed to provide vertebral stability, restore alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used. Silicon nitride (Si3N4) is an alternative material with good osteointegrative properties. This study was designed to assess if Si3N4 cages perform similar to PEEK. Methods: A non-inferiority double-blind multicenter RCT was designed. Patients presenting with chronic low-back pain with or without leg pain were included. Single- or double-level instrumented transforaminal lumbar interbody fusion (TLIF) using an oblique PEEK or Si3N4 cage was performed. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ). The non-inferiority margin for the RMDQ was 2.6 points on a scale of 24. Secondary outcomes included the Oswestry Disability Questionnaire (ODI), Visual Analogue Scales (VAS), SF-36 Physical Function, patient and surgeon Likert scores, radiographic evaluations for subsidence, segmental motion, and fusion. Follow-up was planned at 3, 6, 12, and 24-months. Results: Ninety-two patients were randomized ( i.e. 48 to PEEK and 44 to Si3N4). Both groups showed good clinical improvements on the RMDQ scores of up to 5-8 points during follow-up. No statistically significant differences were observed in clinical and radiographic outcomes. Mean operative time and blood loss were statistically significantly higher for the Si3N4 cohort. Although not statistically significant, there was a higher incidence of complications and revisions associated with the Si3N4 cage. Conclusions: There was insufficient evidence to conclude that Si3N4 was non-inferior to PEEK.

Study Design. Retrospective analysis was performed on data from 251 patients that were included in two randomized, double-blinded clinical trials comparing clinical results of anterior cervical discectomy and arthroplasty (ACDA) to anterior cervical discectomy and fusion (ACDF), and anterior cervical discectomy (ACD), for single-level disc herniation. Objective. This study aimed to investigate whether the ACDA procedure offers superior clinical results 2 years after surgery, to either ACDF or ACD without instrumentation, in the entire group of patients or in a particular subgroup of patients. Summary of Background Data. The cervical disc prosthesis was introduced to provide superior clinical outcomes after ACD. Methods. Neck Disability Index (NDI), and subscales of the 36-item short-form health survey (SF-36) and McGill pain score were collected at baseline, 1 year and 2 years after surgery. Reoperations and complications were also evaluated. A preliminary subgroup analysis was performed for age, disc height, body mass index (BMI), smoking, and sex. Results. The NDI decreased comparably in all treatment arms to circa 50% of the baseline value and marginal mean NDI differences varied from 0.4 to 1.1 on a 100 point NDI scale, with confidence intervals never exceeding the 20-point minimal clinical important difference (MCID). Secondary outcome parameters showed comparable results. Preliminary subgroup analysis could not demonstrate clinically relevant differences in NDI between treatments after 2 years. Conclusion. After combining data from two Randomized Controlled Trials it can be concluded that there is no clinical benefit for ACDA, when compared with ACDF or ACD 2 years after surgery. Preliminary subgroup analysis indicated outcomes were similar between treatment groups, and that no subgroup could be appointed that benefited more from either ACD, ACDF, or ACDA.

Purpose Cervical spine surgery may affect sagittal alignment parameters and induce accelerated degeneration of the cervical spine. Cervical sagittal alignment parameters of surgical patients will be correlated with radiological adjacent segment degeneration (ASD) and with clinical outcome parameters. Methods Patients were analysed from two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF) and without intervertebral cage (ACD). C2–C7 lordosis, T1 slope, C2–C7 sagittal vertical axis (SVA) and the occipito-cervical angle (OCI) were determined as cervical sagittal alignment parameters. Radiological ASD was scored by the combination of decrease in disc height and anterior osteophyte formation. Neck disability index (NDI), SF-36 PCS and MCS were evaluated as clinical outcomes. Results The cervical sagittal alignment parameters were comparable between the three treatment groups, both at baseline and at 2-year follow-up. Irrespective of surgical method, C2–C7 lordosis was found to increase from 11° to 13°, but the other parameters remained stable during follow-up. Only the OCI was demonstrated to be associated with the presence and positive progression of radiological ASD, both at baseline and at 2-year follow-up. NDI, SF-36 PCS and MCS were demonstrated not to be correlated with cervical sagittal alignment. Likewise, a correlation with the value or change of the OCI was absent. Conclusion OCI, an important factor to maintain horizontal gaze, was demonstrated to be associated with radiological ASD, suggesting that the occipito-cervical angle influences accelerated cervical degeneration. Since OCI did not change after surgery, degeneration of the cervical spine may be predicted by the value of OCI. NECK trial Dutch Trial Register Number NTR1289. PROCON trial Trial Register Number ISRCTN41681847. Graphic abstract These slides can be retrieved under Electronic Supplementary Material.

BACKGROUND Motion preservation prostheses were introduced to prevent adjacent disc degeneration (ASD) and to diminish neck disability in the postsurgical follow-up. However, it is still a controversial issue, and the relationship between range of motion (ROM) and ASD has not been studied. PURPOSE To compare the correlation between ROM of the cervical spine and the presence of radiological ASD after anterior discectomy. Clinical outcome was also correlated to ROM and ASD. STUDY DESIGN Retrospective cohort study. METHODS In all, 253 patients who underwent anterior discectomy for cervical radiculopathy due to a herniated disc were analyzed for segmental and global cervical ROM and the presence of ASD both preoperatively, and 12 and 24 months postoperatively. Patients who were included in two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty, anterior cervical discectomy with intervertebral cage, or anterior cervical discectomy without intervertebral cage for one level disc herniation were analyzed. ROM was defined by a custom-developed image analysis tool. ASD was defined by decrease in disc height and anterior osteophyte formation on X-rays. Clinical outcome was evaluated by means of the Neck Disability Index (NDI). RESULTS Two years postoperatively, no correlation was demonstrated between ROM and ASD. The incidence of ASD was comparable in the three groups, being 34% at baseline, and 58% at 2-year follow-up. Likewise, ASD progression was comparable in the three treatment arms. No correlation was demonstrated between ROM and NDI or ASD and NDI. CONCLUSIONS Since ROM is not correlated to ASD, and clinical outcome is not correlated to ROM either, the relevance of continued ROM at the target level seems absent. ispartof: The Spine Journal vol:19 issue:11 pages:1816-1823 ispartof: location:United States status: published

Background: Awareness of treatment group assignment in a clinical trial may influence patient behavior and bias outcome reporting. The objective of this study was to compare 2-year clinical outcomes in blinded vs unblinded patients who were treated with lumbar discectomy and a bone-anchored annular closure device (ACD) for prevention of lumbar disc reherniation. Methods: This was a secondary analysis of a randomized trial comparing lumbar discectomy with (n=272) vs without (n=278) implantation of a bone-anchored ACD. Among patients who received ACD implantation, 35 (13%) were blinded and 237 (87%) were unblinded to treatment allocation. In patients treated with ACD, propensity score-matching (1:1) was performed to account for imbalances in patient characteristics between blinded and unblinded groups. Key clinical outcomes were back pain severity (0–100 scale), leg pain severity (0–100 scale), Oswestry Disability Index (ODI, 0–100 scale), symptomatic reherniation, reoperation at the treated lumbar level, and device-or procedure-related serious adverse events (AEs). Outcomes were reported through 2 years of follow-up, which coincided with the time at which blinded patients were unblinded. Results: There were no statistically significant differences in 2-year outcomes between propensity score-matched blinded (n=35) and unblinded (n=35) patients treated with the ACD. In blinded vs unblinded ACD patients compared to baseline, back pain severity decreased by 40 vs 37 points (P=0.61), leg pain severity decreased by 75 points in each group (P>0.99), and ODI decreased by 47 vs 43 points (P=0.19). The risks of symptomatic reherniation (5.7% vs 9.1%; P=0.59), reoperation (8.6% vs 12.2%, P=0.62), and device-or procedure-related serious AEs (5.7% vs 8.9%, P=0.63) were comparably low in blinded and unblinded patients. Conclusion: In patients treated with lumbar discectomy and a bone-anchored ACD, there were no clinically important or statistically significant differences in back pain, leg pain, ODI, symptomatic reherniation, reoperation, or serious AEs over 2 years of follow-up when comparing patients who were blinded vs unblinded to their treatment assignment. The main limitations of this study were the post hoc nature of the analysis and the potential for bias due to surgeon awareness of treatment assignment.

BACKGROUND: During lumbar spinal fusion, spacer cages are implanted to provide vertebral stability, restore sagittal alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used by most spine surgeons. Silicon nitride (Si(3)N(4)) is a less well-known alternative although it was first used as a spacer in lumbar fusion over 30 years ago. The present study was designed to see if Si(3)N(4) cages would perform similarly to PEEK in a randomized controlled trial. METHODS: A non-inferiority multicenter 100-patient study was designed where both the observer and patient were blinded. Single- or double-level transforaminal lumbar interbody fusion with pedicle screw fixation using an oblique PEEK or Si(3)N(4) cage was performed. The primary non-inferiority outcome was the Roland-Morris Disability Questionnaire (RMDQ). Secondary measures included the Oswestry Disability Questionnaire, Visual Analogue Scales (VAS) for back and leg pain, SF-36 Physical and Mental Function indices, patient and surgeon Likert scores on perceived recovery, and X-ray and CT radiological evaluations for subsidence, segmental motion, and fusion. Follow-up evaluations occurred at 3, 6, 12, and 24 months. RESULTS: After exclusions for protocol violations and canceled surgeries, 92 patients were randomized (i.e., 48 for PEEK and 44 for Si(3)N(4)). There were no differences in baseline demographics, pre-operative disabilities, or pain scores between the groups. Both treatment arms showed significant improvements in disability, pain, and recovery scores. No significant differences were observed for subsidence, segmental motion, or fusion. For the primary outcome (i.e., RMDQ scores), the non-inferiority of Si(3)N(4) compared to PEEK could not be established using the original protocol criteria. However, the comparison was undermined by larger than anticipated patient fallout coupled with higher than expected RMDQ score standard deviations. A post hoc analysis coupled with a more extensive review of the literature was conducted which resulted in the selection of a revised clinically justified non-inferiority margin; and using this method, the non-inferiority of Si(3)N(4) was affirmed. CONCLUSIONS: This study demonstrated that the use of either PEEK or Si(3)N(4) cages is safe and effective for patients undergoing lumbar spine fusion for chronic degenerative disc disease.

BACKGROUND CONTEXT: Anterior cervical discectomy with an interbody cage (ACDF) to obtain fusion is a common procedure in cervical spine surgery. Presently, polyetheretherketone (PEEK) with (auto) graft is frequently used for interbody fusion although alternative implant tech- nology like 3-D printing titanium has been introduced recently. PURPOSE: Reporting the clinical and quantitative radiological outcome of a prospective cohort of 3-D printed porous titanium implants. STUDY DESIGN/SETTING: Prospective study of patients with single level ACDF using 3-D printed porous titanium cervical implants. These data were compared with 48 patients from the PEEK with autograft group of the previously performed CAncellous Structured Ceramic Arthrode- sis DEvice trial. PATIENT SAMPLE: Fourty-nine patients were included. OUTCOME MEASURES: Neck disability index (NDI), visual analog scale (VAS), self -reported perceived recovery, and fusion status. METHODS: The clinical outcomes and fusion rates were documented at 3, 6, and 12 months. Dynamic X-rays were analyzed to determine range of motion (ROM) of the operated level. Fusion was defined as rotation

Study Design. A prospective multicenter cohort study.Objective. To assess the clinical accuracy of six commonly cited prognostic scoring systems for patients with spinal metastases.Summary of Background Data. There are presently several available methods for the estimation of prognosis in metastatic spinal disease, but none are universally accepted by surgeons for clinical use. These scoring systems have not been rigorously tested and validated in large datasets to see if they are reliable enough to inform day-to-day patient management decisions. We tested these scoring systems in a large cohort of patients. A total of 1469 patients were recruited into a secure internet database, and prospectively collected data were analyzed to assess the accuracy of published prognostic scoring systems.Methods. We assessed six prognostic scoring systems, described by the first authors Tomita, Tokuhashi, Bauer, van der Linden, Rades, and Bollen. Kaplan-Meier survival estimates were created for different patient subgroups as described in the original publications. Harrell's C-statistic was calculated for the survival estimates, to assess the concordance between estimated and actual survival.Results. All the prognostic scoring systems tested were able to categorize patients into separate prognostic groups with different overall survivals. However none of the scores were able to achieve "good concordance" as assessed by Harrell's C-statistic. The score of Bollen and colleagues was found to be the most accurate, with a Harrell's C-statistic of 0.66.Conclusion. No prognostic scoring system was found to have a good predictive value. The scores of Bollen and Tomita were the most effective with Harrell's C-statistic of 0.66 and 0.65, respectively. Prognostic scoring systems are calculated using data from previous years, and are subject to inaccuracies as treatments advance in the interim. We suggest that other methods of assessing prognosis should be explored, such as prognostic risk calculation.

It is still a controversial issue that whether cervical disc prostheses can prevent adjacent segment degeneration. In this study, current data tend to indicate that the advantage of cervical prosthesis in preventing radiological adjacent segment degeneration is absent., Study Design. Retrospective analysis using data from RCTs. Objective. This study aimed to report on the incidence of radiological adjacent segment degeneration (ASD) in patients with cervical radiculopathy due to a herniated disc that were randomized to receive cervical arthroplasty or arthrodesis. Summary of Background Data. Cervical disc prostheses were introduced to prevent ASD in the postsurgical follow-up. However, it is still a controversial issue. Methods. Two hundred fifty-three patients were included in two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF), or without intervertebral cage (ACD) for one-level disc herniation. Neutral lateral radiographs were obtained preoperatively, at 1- and 2-year follow-up after surgery. Radiological ASD was evaluated on X-ray and defined by a decrease in disc height and the presence of anterior osteophyte formation on both the superior and the inferior level in relation to the target level. Results. Radiological ASD was present in 34% of patients at baseline and increased to 59% at 2-year follow-up in the arthrodesis groups (ACD and ACDF combined), and to 56% in the arthroplasty group. Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up. Conclusions. Radiological ASD occurs in a similar manner in patients who were subjected to arthrodesis in cervical radiculopathy and in patients who received arthroplasty to maintain motion. Current data tend to indicate that the advantage of cervical prosthesis in preventing radiological ASD is absent. Level of Evidence: 2

Background Meta-analyses on the comparison between fusion and prosthesis in the treatment of cervical radiculopathy mainly analyse studies including mixed patient populations: patients with radiculopathy with and without myelopathy. The outcome for patients with myelopathy is different compared to those without. Furthermore, apart from decompression of the spinal cord, restriction of motion is one of the cornerstones of the surgical treatment of spondylotic myelopathy. From this point of view, the results for arthroplasty might be suboptimal for this category of patients. Comparing clinical outcome in patients exclusively suffering from radiculopathy is therefore a more valid method to compare the true clinical effect of the prosthesis to that of fusion surgery. Aim The objective of this study was to compare clinical outcome of cervical arthroplasty (ACDA) to the clinical outcome of fusion (ACDF) after anterior cervical discectomy in patients exclusively suffering from radiculopathy, and to evaluate differences with mixed patient populations. Methods A literature search was completed in PubMed, EMBASE, Web of Science, COCHRANE, CENTRAL and CINAHL using a sensitive search strategy. Studies were selected by predefined selection criteria (i.a.) patients exclusively suffering from cervical radiculopathy), and risk of bias was assessed using a validated Cochrane Checklist adjusted for this purpose. An additional overview of results was added from articles considering a mix of patients suffering from myelopathy with or without radiculopathy. Results Eight studies were included that exclusively compared intervertebral devices in radiculopathy patients. Additionally, 29 articles concerning patients with myelopathy with or without radiculopathy were studied in a separate results table. All articles showed intermediate to high risk of bias. There was neither a difference in decrease in mean NDI score between the prosthesis (20.6 points) and the fusion (20.3 points) group, nor was there a clinically important difference in neck pain (VAS). Comparing these data to the mixed population data demonstrated comparable mean values, except for the 2-year follow-up NDI values in the prosthesis group: mixed group patients that received a prosthesis reported a mean NDI score of 15.6, indicating better clinical outcome than the radiculopathy patients that received a prosthesis though not reaching clinical importance. Conclusions ACDF and ACDA are comparably effective in treating cervical radiculopathy due to a herniated disc in radiculopathy patients. Comparing the 8 radiculopathy with the 29 mixed population studies demonstrated that no clinically relevant differences were present in clinical outcome between the two types of patients. Graphic abstract These slides can be retrieved under Electronic Supplementary Material.

BACKGROUND Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical radiculopathy was introduced to prevent symptomatic adjacent disc degeneration as compared with anterior cervical discectomy and fusion (ACDF). Prior reports suggest that ACDF is not more effective than anterior cervical discectomy (ACD) alone for the treatment of cervical radiculopathy. PURPOSE To evaluate whether patients with cervical radiculopathy due to a herniated disc benefit more from undergoing ACDA, ACDF, or ACD in terms of clinical outcome measured by the neck disability index (NDI). STUDY DESIGN Double-blinded randomized controlled trial. METHODS One hundred-nine patients with one level herniated disc were randomized to one of the following treatments: ACDA, ACDF with intervertebral cage, ACD without fusion. Clinical and radiological outcome was measured by NDI, Visual Analogue Scale (VAS) neck pain, VAS arm pain, SF36, EQ-5D, patients’ self-reported perceived recovery, radiographic cervical curvature, and adjacent segment degeneration parameters at baseline and until two years after surgery. BBraun Medical paid €298.837 to cover the costs for research nurses. RESULTS The NDI declined from 41 to 47 points at baseline to 19 ± 15 in the ACD group, 19 ± 18 in the ACDF group, and 20 ± 22 in the ACDA group after surgery (p=.929). VAS arm and neck pain declined to half its baseline value and decreased below the critical value of 40 mm. Quality of life, measured by the EQ-5D, increased in all three groups. Adjacent segment degeneration parameters were comparable in all three groups as well. No statistical differences were demonstrated between the treatment groups. CONCLUSIONS The hypothesis that ACDA would lead to superior clinical outcome in comparison to ACDF or ACD could not be confirmed during a 2-year follow-up time period. Single level ACD without implanting an intervertebral device may be a reasonable alternative to ACDF or ACDA.

BACKGROUND CONTEXT Lumbar discectomy is typically successful in reducing pain and neurological dysfunction when conservative treatment fails; however, approximately 30% of patients experience readmissions from device- or procedure-related serious adverse events. Large defects (≥ 6 mm wide) in the annulus fibrosis are a significant risk factor for readmission. Early results with occluding such defects with an annular closure device (ACD) have been promising in reducing readmission rates, but long-term outcomes have not been reported. PURPOSE To examine the readmission rates of the randomized, prospective, multicenter trial at 4 years. METHODS Primary discectomy patients at 21 sites were randomized intraoperatively 1:1 for treatment with discectomy alone (control, 278 patients) or discectomy followed by the ACD (272 patients). Inclusion criteria included 6 weeks conservative care, minimum Oswestry Disability Index (ODI) and visual analog scale (VAS) for leg pain scores (40/100), 5 mm minimum posterior disc height, and an intraoperatively measured annular defect width of 6-10 mm. Readmissions were identified as device- or procedure-related SAEs, as adjudicated by 4 clinicians. Survival analysis and univariate Cox regression using all participants were used to calculate readmission rates and hazard ratios (HRs) of demographic factors, respectively. RESULTS A total of 463 of 550 subjects (84.2%) was assessed at 4 years: 229 of 278 (82.4%) control and 234 of 272 (86.0%) ACD. The overall readmission rates for the control and ACD groups were 19.8% and 12.2%, respectively (p = 0.0099, log-rank test). ACD deficiency was observed in 11 subjects (4.0%). Reherniation at the index level occurred in 46 (16.5%) control and 18 (6.6%) ACD participants (p CONCLUSIONS Occluding annular defects ≥ 6 mm by augmenting lumbar discectomy with an ACD reduced readmission by 38.4% at 4 years, primarily due to a reduction in reherniation at the index level. Female gender and smoking were risk factors for readmission. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Objective The objective of this study was to review current literature on the comparison of the radiological outcome of cervical arthroplasty with fusion after anterior discectomy for radiculopathy. Materials and Methods A literature search was performed in PubMed, Embase, Web of Science, Cochrane, CENTRAL, and CINAHL using a sensitive search string combination. Studies were selected by predefined selection criteria (patients exclusively suffering from cervical radiculopathy), and risk of bias was assessed using a validated Cochrane checklist adjusted for this purpose. Additionally, an overview of results of articles published in 21 meta-analyses was added, considering a group of patients with myelopathy with or without radiculopathy. Results Seven articles that compared intervertebral devices in patients with radiculopathy (excluding patients with myelopathy) were included in the study. Another 31 articles were studied as a mixed group, including patients with myelopathy and radiculopathy. Apart from three studies with low risk of bias, all other articles showed intermediate or high risk of bias. Heterotopic ossification was reported to be present in circa 10% of patients, seemingly predominant in patients with radiculopathy, with a very low level of evidence. Radiological signs of adjacent segment disease were present at baseline in 50% of patients, and there is a low level of evidence that this increased more (10%–20%) in the fusion group at long-term follow-up. However, this was only studied in the mixed study population, which is degenerative by diagnosis. Conclusion Although the cervical disc prosthesis was introduced to decrease adjacent level disease, convincing radiological evidence for this benefit is lacking. Heterotopic ossification as a complicating factor in the preservation of motion of the device is insufficiently studied. Regarding purely radiological outcomes, currently, no firm conclusion can be drawn for implanting cervical prosthesis versus performing fusion.

BACKGROUND Lumbar disc surgery for radicular leg pain is one of the most frequently performed spine procedures. In approximately 20% of patients poor outcome is achieved. The most complex cases have persistent leg pain without residual nerve root compression. Treatment for refractory cases is limited to medical pain management, spinal cord stimulation (SCS), and dorsal root ganglion stimulation. For the latter two, fair to good results are obtained in only 50% of patients and costs and complication rates are high. An alternative surgical procedure is selective intradural dorsal rhizotomy (SIDR). This procedure has been largely abandoned, likely due to poor historic results and readily available modern alternatives. PURPOSE The goal of this paper is to report our results for SIDR for persistent monoradicular leg pain without residual nerve root compression and to compare the results with those of SCS. STUDY DESIGN Prospectively followed case series. PATIENT SAMPLE Consecutive patients with persistent monoradicular leg pain without residual nerve root compression. OUTCOME MEASURES Visual Analogue Scale (VAS) for leg pain, Roland Disability Questionnaire, and Likert Scale for leg pain were recorded. Complications were documented and patients were asked if, in retrospect, they would undergo the procedure again. METHODS In Haaglanden Medical Center, SIDR was performed on eight consecutive patients with persistent monoradicular leg pain without residual nerve root compression between December 2013 and September 2017. Patients were followed prospectively and VAS for leg pain, Roland Disability Questionnaire (RDQ), and Likert Scale for leg pain were recorded at intake, 8 weeks and 1 year after surgery and yearly after that. Minimal clinically important differences (MCID) for VAS and RDQ were predefined. Means and ranges were calculated and due to the small sample size further analysis was limited to descriptive analysis. RESULTS Mean follow-up was 20 months. VAS for leg pain improved from 80 mm at intake to 34 mm at latest follow-up. Five out of eight patients (63%) had good Likert Scale outcome (complete or near complete recovery of leg pain). Patients scored 19, 5 on the RDQ at intake and 12, 7 at the end of follow-up. Four patients (57%) reached a MCID for VAS at 1 year post surgery and one reached borderline MCID. Five patients (71%) reached a MCID for RDQ at 1 year post surgery. Six patients (75%) would undergo the procedure again. CONCLUSIONS SIDR is a safe and effective procedure in strictly selected patients with persistent monoradicular leg pain without residual nerve root compression. Considering the high costs and complication rates of SCS, the results of this study warrant a randomized controlled trial comparing the cost-effectiveness of SIDR and SCS.

Anterior cervical spine surgery is associated with postoperative dysphagia, sore throat and dysphonia. It is unclear, whether this is caused by increased endotracheal tube (ETT) cuff pressure after retractor placement. This study aims to assess the effect of ETT cuff pressure adjustment on postoperative dysphagia, sore throat and dysphonia. In this, single-centre, observer and patient-blinded randomized controlled trial patients treated with anterior cervical spine surgery were randomized to adjustment of the ETT cuff pressure to 20 mmHg after placement of the retractor versus no adjustment. Primary outcome was the incidence and severity of postoperative dysphagia. Secondary outcomes were sore throat and dysphonia. Outcomes were evaluated on day one and 2 months after the operation. Of 177 enrolled patients, 162 patients (92.5%) could be evaluated. The incidence of dysphagia was 75.9% on day one and 34.6% 2 months after surgery. Dysphagia in the intervention and control group was present in 77.8% versus 74.1% of patients on day one (odds ratio (OR) 1.2, 95% confidence interval (CI) (0.6–2.5)) and 28.4% versus 40.7% of patients after 2 months (OR 0.6, 95% CI 0.3–1.1), respectively. Severity of dysphagia, sore throat and dysphonia was similar in both groups. Anterior cervical spine surgery is accompanied by a high incidence of postoperative dysphagia, lasting until at least 2 months after surgery in over a third of our patients. Adjusting ETT cuff pressure to 20 mmHg after retractor placement, as compared to controls, did not lower the risk for both short- and long-term dysphagia. Netherlands National Trial Registry Number: NTR 3542. These slides can be retrieved under electronic supplementary material.

Background Context: Patients with large annular defects after lumbar discectomy for disc herniation are at high risk of symptomatic recurrence and reoperation. Purpose: The present study aimed to determine whether a bone-anchored annular closure device, in addition to lumbar microdiscectomy, resulted in lower reherniation and reoperation rates plus increased overall success compared with lumbar microdiscectomy alone. Design: This is a multicenter, randomized superiority study. Patient Sample: Patients with symptoms of lumbar disc herniation for at least 6 weeks with a large annular defect (6–10 mm width) after lumbar microdiscectomy were included in the study. Outcome Measures: The co-primary end points determined a priori were recurrent herniation and a composite end point consisting of patient-reported, radiographic, and clinical outcomes. Study success required superiority of annular closure on both end points at 2-year follow-up. Methods: Patients received lumbar microdiscectomy with additional bone-anchored annular closure device (n=276 participants) or lumbar microdiscectomy only (control; n=278 participants). This research was supported by Intrinsic Therapeutics. Two authors received study-specific support morethan $10,000 per year, 8 authors received study-specific support less than $10,000 per year, and 11 authors received no study-specific support. Results: Among 554 randomized participants, 550 (annular closure device: n=272; control: n=278) were included in the modified intent-to-treat efficacy analysis and 550 (annular closure device: n=267; control: n=283) were included in the as-treated safety analysis. Both co-primary end points of the study were met, with recurrent herniation (50% vs. 70%, P

BACKGROUND CONTEXT: Percutaneous laser disc decompression (PLDD) is a minimally invasive treatment for lumbar disc herniation, with Food and Drug Administration approval since 1991. However, no randomized trial comparing PLDD to conventional treatment has been performed. PURPOSE: In this trial, we assessed the effectiveness of a strategy of PLDD as compared with conventional surgery. STUDY DESIGN/SETTING: This randomized prospective trial with a noninferiority design was carried out in two academic and six teaching hospitals in the Netherlands according to an intent-to-treat protocol with full institutional review board approval. PATIENT SAMPLE: One hundred fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were included. OUTCOME MEASURES: The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analog scores for back and leg pain, and the patient's report of perceived recovery. METHODS: Patients were randomly allocated to PLDD (n=57) or conventional surgery (n=58). Blinding was impossible because of the nature of the interventions. This study was funded by the Healthcare Insurance Board of the Netherlands. RESULTS: The primary outcome, Roland-Morris Disability Questionnaire, showed noninferiority of PLDD at 8 (-0.1; [95% confidence interval (CI), -2.3 to 2.1]) and 52 weeks (-1.1; 95% CI, -3.4 to 1.1) compared with conventional surgery. There was, however, a higher speed of recovery in favor of conventional surgery (hazard ratio, 0.64 [95% CI, 0.42-0.97]). The number of reoperations was significantly less in the conventional surgery group (38% vs. 16%). Overall, a strategy of PLDD, with delayed surgery if needed, resulted in noninferior outcomes at 1 year. CONCLUSIONS: At 1 year, a strategy of PLDD, followed by surgery if needed, resulted in noninferior outcomes compared with surgery. (C) 2015 Elsevier Inc. All rights reserved.

The diversity among the current international practice patterns and the discrepancy between the eminence-based medicine and the evidence-based medicine in the treatment of lumbar disk herniation is presented. Minimally invasive techniques were expected to give the lowest postoperative low back pain, however, also to give the highest risk of recurrent disk herniation.A questionnaire survey.To evaluate the current practice patterns of surgeons regarding both the surgical and nonsurgical management of lumbar disk herniation (LDH) worldwide and to compare this with the current literature.Sciatica is a common diagnosis in the general population. Sciatica is most frequently caused by LDH. Multiple surgical techniques and treatment modalities are available to treat LDH, albeit some with small effect sizes or without compelling evidence.A survey including questions on the application of physical examination, expectations regarding different surgical and nonsurgical techniques, factors influencing the outcome of surgery were distributed among members of AOSpine International and the European Association of Neurosurgical Societies.Eight hundred and seventeen surgeons from 89 countries completed the questionnaire. These surgeons perform a total of 62.477 discectomies yearly. Pain medication and steroid injections were expected to be the most effective nonsurgical treatments. The severity of pain and/ or disability and failure of conservative therapy were the most important indications for surgery. A period of 1 to 2 months of radiculopathy was regarded as a minimum for indicating surgery. Unilateral transflaval discectomy was the procedure of choice among the majority and was expected to be the most effective technique with the lowest complication risk. Surgeons performing more lumbar discectomies, with more clinical experience and those located in Asia, were more likely to offer minimally invasive surgical techniques.This study shows that current international practice patterns for LDH surgery are diverse. There seems to be a discrepancy between preferred surgical techniques and the attitudes of surgeons worldwide and the evidence. Further research should focus on developing international guidelines to reduce practice variety and offer patients the optimal treatment for LDH.N/A.A questionnaire survey. To evaluate the current practice patterns of surgeons regarding both the surgical and nonsurgical management of lumbar disk herniation (LDH) worldwide and to compare this with the current literature. Sciatica is a common diagnosis in the general population. Sciatica is most frequently caused by LDH. Multiple surgical techniques and treatment modalities are available to treat LDH, albeit some with small effect sizes or without compelling evidence. A survey including questions on the application of physical examination, expectations regarding different surgical and nonsurgical techniques, factors influencing the outcome of surgery were distributed among members of AOSpine International and the European Association of Neurosurgical Societies. Eight hundred and seventeen surgeons from 89 countries completed the questionnaire. These surgeons perform a total of 62.477 discectomies yearly. Pain medication and steroid injections were expected to be the most effective nonsurgical treatments. The severity of pain and/ or disability and failure of conservative therapy were the most important indications for surgery. A period of 1 to 2 months of radiculopathy was regarded as a minimum for indicating surgery. Unilateral transflaval discectomy was the procedure of choice among the majority and was expected to be the most effective technique with the lowest complication risk. Surgeons performing more lumbar discectomies, with more clinical experience and those located in Asia, were more likely to offer minimally invasive surgical techniques. This study shows that current international practice patterns for LDH surgery are diverse. There seems to be a discrepancy between preferred surgical techniques and the attitudes of surgeons worldwide and the evidence. Further research should focus on developing international guidelines to reduce practice variety and offer patients the optimal treatment for LDH. Level of Evidence: N/A.

Item does not contain fulltext BACKGROUND: Cervical spondylotic myelopathy is frequently encountered in neurosurgical practice. The posterior surgical approach includes laminectomy and laminoplasty. OBJECTIVE: To perform a systematic review evaluating the effectiveness of posterior laminectomy compared with posterior laminoplasty for patients with cervical spondylotic myelopathy. METHODS: An extensive search of the literature in Pubmed, Embase, and Cochrane library was performed by an experienced librarian. Risk of bias was assessed by two authors independently. The quality of the studies was graded, and the following outcome measures were retrieved: pre- and postoperative (m)JOA, pre- and postoperative ROM, postoperative VAS neck pain, and Ishira cervical curvature index. If possible data were pooled, otherwise a weighted mean was calculated for each study and a range mentioned. RESULTS: All studies were of very low quality. Due to inadequate description of the data in most articles, pooling of the data was not possible. Qualitative interpretation of the data learned that there were no clinically important differences, except for the higher rate of procedure-related complications with laminoplasty. CONCLUSION: Based on these results, a claim of superiority for laminoplasty or laminectomy was not justified. The higher number of procedure-related complications should be considered when laminoplasty is offered to a patient as a treatment option. A study of robust methodological design is warranted to provide objective data on the clinical effectiveness of both procedures.

Study design Prospective cohort study. Background Although lumbar radiculopathy is regarded as a specific diagnosis, the most effective treatment strategy is unclear. Commonly used treatments include transforaminal epidural steroid injections (TESIs) and Mechanical Diagnosis & Therapy (MDT), but no studies have investigated the effectiveness of this combination. MDT differentiates pain centralization (C) from non-centralization (NC), which indicates good vs. poor prognostic validity respectively. Objective The main aims were 1) to determine changes in Mechanical Diagnosis and Therapy (MDT) pain response classifications after transforaminal epidural steroid injections (TESIs) in candidates for lumbar herniated disc surgery and 2) to evaluate differences in short and long term outcomes for patients with different pain response classifications. Methods Candidates for lumbar herniated disc surgery were assessed with a MDT protocol and their pain response classified as centralizing or peripheralizing. For this study,only patients were eligible who showed a peripheralizing pain response at intake. All patients then received TESIs and were reassessed and classified using the MDT protocol, into groups according to pain response (resolved, centralizing, peripheralizing with less pain and peripheralising with severe pain). After receiving targeted treatment based on pain response after TESIs, ranging from advice, MDT or surgery, follow-up assessments were completed at discharge and at 12 months. The primary outcomes were disability (Roland-Morris Disability Questionnaire [RMDQ] for Sciatica), pain severity in leg (visual analogue scale [VAS], 0-100) and global perceived effect (GPE). Linear mixed-models were used to determine between-groups differences in outcome. Results A total of 77 patients with lumbar disc herniation and peripheralizing symptoms were included. Patients received an average of 2 (SD 0.7) TESIs. After TESIs, 17 patients (22%) were classified as peripheralizing with continuing severe pain.These patients underwent surgery and were not further evaluated. Eleven (14%) patients were classified as resolved, 37 (48%) as centralizing with significant less pain, and 12 (16%) as peripheralizing with significant less pain. None of these patients underwent surgery. Resolved and centralizer subgroups had better outcomes in terms of VAS and RMDQ than the non-operated peripheralizers at discharge and at 12 months. The succes rates (GPE) for the resolved, centralizing, and peripheralizing with less pain patients were 100%, 100% and 33% respectively at short term, and 100%, 92% and 50% respectively at long term. Conclusion After TESIs, a peripheralizing pain pattern changed to resolved or centralizing in 62% of the patients. For the non-operated patients, those with a centralising pattern after TESIs reported better pain and disability outcomes than those with peripheralizing pattern at short and long term.

Anterior cervical discectomy with fusion is a common procedure for treating radicular arm pain. Polyetheretherketone (PEEK) plastic is a frequently used material in cages for interbody fusion. Silicon nitride is a new alternative with desirable bone compatibility and imaging characteristics. The aim of the present study is to compare silicon nitride implants with PEEK cages filled with autograft harvested from osteophytes. The study is a prospective, randomized, blinded study of 100 patients with 2 years follow-up. The primary outcome measure was improvement in the Neck Disability Index. Other outcome measures included SF-36, VAS arm pain, VAS neck pain, assessment of recovery, operative characteristics, complications, fusion and subsidence based on dynamic X-ray and CT scan. There was no significant difference in NDI scores between the groups at 24 months follow-up. At 3 and 12 months the NDI scores were in favor of PEEK although the differences were not clinically relevant. On most follow-up moments there was no difference in VAS neck and VAS arm between both groups, and there was no statistically significant difference in patients’ perceived recovery during follow-up. Fusion rate and subsidence were similar for the two study arms and about 90% of the implants were fused at 24 months. Patients treated with silicon nitride and PEEK reported similar recovery rates during follow-up. There was no significant difference in clinical outcome at 24 months. Fusion rates improved over time and are comparable between both groups.

To evaluate long-term clinical and radiological results of cervical laminectomy without adjuvant-instrumented fusion for degenerative spinal cord compression. A retrospective follow-up study of patients in which clinical data (n = 207), questionnaires (n = 96) and fluoroscopy (n = 77) were reviewed. Postoperative perceived recovery was reported by 76 and 63 % of patients at 3 months and 9 years, respectively. Functional status remained unchanged. The incidence of kyphosis and segmental instability was 15 and 18 %, respectively, and occurred almost exclusively if preoperative lordosis was

COMMENTARY ON Kepler CK, Yu AL, Gruskay JA, et al. Comparison of open and minimally invasive techniques for posterior lumbar instrumentation and fusion after open anterior lumbar interbody fusion. Spine J 2013;13:489–97 ( in this issue ).

Expandable cages are widely used to reconstruct the spine after the removal of vertebral metastases. Long-term results, however, are lacking, and there is little information on reconstruction after multilevel corpectomies.To determine long-term outcome for reconstruction of the spine with expandable cages after single and multilevel corpectomies for spinal metastases.A prospective cohort study of 60 consecutive patients with spinal metastases treated with expandable cages.All patients were prospectively followed with regular clinical and radiographic evaluation. Outcome measures were the Frankel score, patients' self-reported recovery, radiological alignment of the spine, and neurologic plus biomechanical complications.Sixty patients were treated with expandable cages in our hospital in a 5-year period with a maximum follow-up of 6 years. Single-level reconstruction was performed in 48 cases, 2-level in 8, and 3-level in 4. Postoperatively, the Frankel score had improved significantly (p=.03), the segment height had increased (p=.02), and, in severe cases of kyphosis (20°), the regional angulation had been corrected compared with preoperatively (p.001). Complication rate, however, was high (36.7%), in particular after multilevel reconstruction, in which three cases had to be reoperated years after the initial surgery; reasons for this were hardware failure, progressive kyphosis, and bronchial perforation. Good recovery was reported in 70% of all patients.Expandable cages can be used successfully in reconstruction of the spine after single and multilevel corpectomies for spinal metastases. However, long-term complication rate is high. Promotion of bony fusion, prevention of soft-tissue damage, adequate posterior stabilization, and careful patient selection may reduce these complications.

Purpose: Assessing the benefits of surgical treatments for sciatica is critical for clinical and policy decision-making. To compare minimally invasive (MI) and conventional microdiscectomy (MD) for patients with sciatica due to lumbar disc herniation. Methods: A systematic review and meta-analysis of controlled clinical trials including patients with sciatica due to lumbar disc herniation. Conventional microdiscectomy was compared separately with: (1) Interlaminar MI discectomy (ILMI vs. MD); (2) Transforaminal MI discectomy (TFMI vs. MD). Outcomes: Back pain, leg pain, function, improvement, work status, operative time, blood loss, length of hospital stay, complications, reoperations, analgesics and cost outcomes were extracted and risk of bias assessed. Pooled effect estimates were calculated using random effect meta-analysis. Results: Twenty-nine studies, 16 RCTs and 13 non-randomised studies (n = 4,472), were included. Clinical outcomes were not different between the surgery types. There is low quality evidence that ILMI takes 11 min longer, results in 52 ml less blood loss and reduces mean length of hospital stay by 1.5 days. There were no differences in complications or reoperations. The main limitations were high risk of bias, low number of studies and small sample sizes comparing TF with MD. Conclusions: There is moderate to low quality evidence of no differences in clinical outcomes between MI surgery and conventional microdiscectomy for patients with sciatica due to lumbar disc herniation. Studies comparing transforaminal MI with conventional surgery with sufficient sample size and methodological robustness are lacking. © 2014 Springer-Verlag.

Background context The optimal surgical treatment of thoracic disc herniations remains controversial and depends on the consistency of the herniation and its location related to the spinal cord. Purpose To compare the outcomes of patients with symptomatic thoracic disc herniations treated with anterolateral mini-transthoracic approach (TTA) versus posterior transpedicular discectomy. Study design This is a prospective comparative cohort study. Patient sample One hundred consecutive patients with symptomatic thoracic herniated discs were operated by mini-TTA (56 patients) or transpedicular discectomy (44 patients). Outcome measures Neurologic assessment by American Spinal Injury Association (ASIA) Impairment Scale and patients' self reported perceived recovery and complications. Methods The consistency and location of the herniated disc in relation to the spinal cord was evaluated by preoperative computed tomography and magnetic resonance imaging. Patients were assessed neurologically before surgery and at regular outpatient controls at 2 months or later. Long-term follow-up was achieved by questionnaires sent by mail. Results In both groups, most patients had symptoms of myelopathy and radicular pain; patients who underwent mini-TTA, more frequently suffered from spasticity. Fifty-eight percent of the herniated discs were calcified and 77% were larger than one-third of the spinal canal. All patients presented with ASIA Grade C or D (64%) or ASIA Grade E (36%). Postoperatively, 50% of the patients treated with mini-TTA and 37% of the transpedicular group improved at least one grade on the ASIA scale (p=.19). The duration of surgery, blood loss, hospital stay, and complication rate were significantly higher in patients treated with mini-TTA and were mainly related to the magnitude and consistency of the herniated disc. At long-term follow-up, 72% of the mini-TTA patients reported good outcome versus 76% of the transpedicular discectomy group (p=.80). Conclusions Surgical treatment of a symptomatic herniated disc contributed to a clinical improvement in most cases. The approach is dependent on the location, the magnitude, and the consistency of the herniated thoracic disc. Medially located large calcified discs should be operated through an anterolateral approach, whereas noncalcified or lateral herniated discs can be treated from a posterior approach as well. For optimal treatment of this rare entity, the treatment should be performed in selected centers.

Evaluation of risk factors for survival in patients surgically treated for symptomatic spinal epidural metastases (SEM).One hundred and six patients who were surgically treated for symptomatic SEM in a 10-year period in two cooperatively working hospitals were retrospectively studied for nine risk factors: age, gender, site of the primary tumor, location of the symptomatic spinal metastasis, functional and neurologic status, the presence of visceral metastases and the presence of other spinal and extraspinal bone metastases. Analysis was performed using the Kaplan-Meier method, univariate log-rank tests and Cox-regression models.Overall median survival was 10.7 months (0.2-107.5 months). Overall 30-day complication rate was 33 %. Multivariate Cox-regression analysis showed that fast growing primary tumors (HR 3.1, 95 % CI 1.6-6.2, p = 0.001), the presence of visceral metastases (HR 1.7, 95 % CI 1.0-2.9, p = 0.033) and a low performance status (HR 2.7, 95 % CI 1.1-6.6, p = 0.025) negatively influenced the survival.Primary tumor type, presence of visceral metastases and performance status are significant predictors for survival after surgery for symptomatic SEM and should be evaluated before deciding on the extent of treatment. More accurate prediction models are needed to select the best treatment option for the individual patient.

In anterior cervical spine surgery a retractor is obligatory to approach the spine. Previous studies showed an increase of endotracheal tube cuff pressure after placement of a retractor. It is known that high endotracheal tube cuff pressure increases the incidence of postoperative dysphagia, hoarseness, and sore throat. However, until now no evidence supports the fact whether adjusting the endotracheal tube cuff pressure during anterior cervical spine surgery will prevent this comorbidity. We present the design of a randomized controlled trial to determine whether adjusting endotracheal tube cuff pressure after placement of a retractor during anterior cervical spine surgery will prevent postoperative dysphagia. 177 patients (aged 18–90 years) scheduled for anterior cervical spine surgery on 1 or more levels will be included. After intubation, endotracheal tube cuff pressure is manually inflated to 20 mm Hg in all patients. Patients will be randomized into two groups. In the control group endotracheal tube cuff pressure is not adjusted after retractor placement. In the intervention group endotracheal tube cuff pressure after retractor placement is maintained at 20 mm Hg and air is withdrawn when cuff pressure exceeds 20 mm Hg. Endotracheal tube cuff pressure is measured after intubation, before and after placement and removal of the retractor. Again air is inflated if cuff pressure sets below 20 mmHg after removal of the retractor. The primary outcome measure is postoperative dysphagia. Other outcome measures are postoperative hoarseness, postoperative sore throat, degree of dysphagia, length of hospital stay, and pneumonia. The study is a single centre double blind randomized trial in which patients and research nurses will be kept blinded for the allocated treatment during the follow-up period of 2 months. Postoperative dysphagia occurs frequently after anterior cervical spine surgery. This may be related to high endotracheal tube cuff pressure. Whether adaptation and maintaining the pressure after placement of the retractor will decrease the incidence of dysphagia, has to be determined by this trial. Netherlands Trial Register (NTR) 3542: http://www.trialregister.nl .

Background Polyetheretherketone (PEEK) cages have been widely used in the treatment of lumbar degenerative disc disorders, and show good clinical results. Still, complications such as subsidence and migration of the cage are frequently seen. A lack of osteointegration and fibrous tissues surrounding PEEK cages are held responsible. Ceramic implants made of silicon nitride show better biocompatible and osteoconductive qualities, and therefore are expected to lower complication rates and allow for better fusion. Purpose of this study is to show that fusion with the silicon nitride cage produces non-inferior results in outcome of the Roland Morris Disability Questionnaire at all follow-up time points as compared to the same procedure with PEEK cages. Methods/Design This study is designed as a double blind multi-center randomized controlled trial with repeated measures analysis. 100 patients (18–75 years) presenting with symptomatic lumbar degenerative disorders unresponsive to at least 6 months of conservative treatment are included. Patients will be randomly assigned to a PEEK cage or a silicon nitride cage, and will undergo a transforaminal lumbar interbody fusion with pedicle screw fixation. Primary outcome measure is the functional improvement measured by the Roland Morris Disability Questionnaire. Secondary outcome parameters are the VAS leg, VAS back, SF-36, Likert scale, neurological outcome and radiographic assessment of fusion. After 1 year the fusion rate will be measured by radiograms and CT. Follow-up will be continued for 2 years. Patients and clinical observers who will perform the follow-up visits will be blinded for type of cage used during follow-up. Analyses of radiograms and CT will be performed independently by two experienced radiologists. Discussion In this study a PEEK cage will be compared with a silicon nitride cage in the treatment of symptomatic degenerative lumbar disc disorders. To our knowledge, this is the first randomized controlled trial in which the silicon nitride cage is compared with the PEEK cage in patients with symptomatic degenerative lumbar disc disorders. Trial registration NCT01557829

Background: Patients who undergo lumbar disc surgery for herniated discs, are advocated two different postoperative management strategies: a watchful waiting policy, or referral for rehabilitation immediately after discharge from the hospital. A direct comparison of the effectiveness and cost-effectiveness of these two strategies is lacking. Methods/Design. A randomised controlled trial will be conducted with an economic evaluation alongside to assess the (cost-) effectiveness of rehabilitation after lumbar disc surgery. Two hundred patients aged 18-70 years with a clear indication for lumbar disc surgery of a single level herniated disc will be recruited and randomly assigned to either a watchful waiting policy for first six weeks or exercise therapy starting immediately after discharge from the hospital. Exercise therapy will focus on resumption of activities of daily living and return to work. Therapists will tailor the intervention to the individual patient's needs. All patients will be followed up by the neurosurgeon six weeks postoperatively. Main outcome measures are: functional status, pain intensity and global perceived recovery. Questionnaires will be completed preoperatively and at 3, 6, 9, 12 and 26 weeks after surgery. Data will be analysed according to the intention-to-treat principle, using a linear mixed model for continuous outcomes and a generalised mixed model for dichotomous outcomes. The economic evaluation will be performed from a societal perspective. Discussion. The results of this trial may lead to a more consistent postoperative strategy for patients who will undergo lumbar disc surgery. Trial registration. Netherlands Trial Register: NTR3156. © 2013 Oosterhuis et al.; licensee BioMed Central Ltd.

INTRODUCTION: Disc herniation with sciatica accounts for five percent of low-back disorders but is one of the most common reasons for spine surgery. The goal of this study was to update the Cochrane review on the effect of surgical techniques for sciatica due to disc herniation, which was last updated in 2007.MATERIALS AND METHODS: In April 2011, we conducted a comprehensive search in CENTRAL, MEDLINE, EMBASE, CINAHL, PEDRO, ICL, and trial registries. We also checked the reference lists and citation tracking results of each retrieved article. Only randomized controlled trials (RCT) of the surgical management of sciatica due to disc herniation were included. Comparisons including chemonucleolysis and prevention of scar tissue or comparisons against conservative treatment were excluded. Two review authors independently selected studies, assessed risk of bias of the studies and extracted data. Quality of evidence was graded according to the GRADE approach.RESULTS: Seven studies from the original Cochrane review were included and nine additional studies were found. In total, 16 studies were included, of which four had a low risk of bias. Studies showed that microscopic discectomy results in a significantly, but not clinically relevant longer operation time of 12 min (95% CI 2-22) and shorter incision of 24 mm (95% CI 7-40) compared with open discectomy, but did not find any clinically relevant superiority of either technique on clinical results. There were conflicting results regarding the comparison of tubular discectomy versus microscopic discectomy for back pain and surgical duration.CONCLUSIONS: Due to the limited amount and quality of evidence, no firm conclusions on effectiveness of the current surgical techniques being open discectomy, microscopic discectomy, and tubular discectomy compared with each other can be drawn. Those differences in leg or back pain scores, operation time, and incision length that were found are clinically insignificant. Large, high-quality studies are needed, which examine not only effectiveness but cost-effectiveness as well.

The rational of minimal invasive lumbar disc surgery was less muscle damage, less back pain, shorter hospitalisation, and faster recovery and resumption of daily activities. Based on our study, however, microtubular discectomy (MTD) did neither result in reduced muscle damage and low back pain nor faster speed of recovery compared to the conventional discectomy. In both procedures the nerve root was decompressed with consequent similar relief of radicular leg pain. Interestingly, patients treated with MTD reported higher scores of low back pain during the follow-up period compared to patients treated with conventional discectomy. Therefore, we agree that MTD should not replace conventional discectomy in patients with lumbar disc herniation. Possibly, minimal invasive surgery is superior to conventional open surgery in patients with instrumented spinal fusion, although it should be evaluated in large randomised controlled trials prior to implantation on a large scale.

Item does not contain fulltext INTRODUCTION: Despite an increasing implantation rate of interspinous process distraction (IPD) devices in the treatment of intermittent neurogenic claudication (INC), definitive evidence on the clinical effectiveness of implants is lacking. The main objective of this review was to perform a meta-analysis of all systematic reviews, randomized clinical trials and prospective cohort series to quantify the effectiveness of IPDs and to evaluate the potential side-effects. METHODS: Data from all studies prospectively describing clinical results based on validated outcome scales and reporting complications of treatment of patients with INC with IPD placement. We searched MEDLINE, EMBASE, Web of Science, Cochrane (CENTRAL), CINAHL, Academic Search Premier, Science Direct up to July 2010. Studies describing patients with INC caused by lumbar stenosis, reporting complication rate and reporting based on validated outcome scores, were eligible. Studies with only instrumented IPD results were excluded. RESULTS: Eleven studies eligible studies were identified. Two independently RCTs and eight prospective cohorts were available. In total 563 patients were treated with IPDs. All studies showed improvement in validated outcome scores after 6 weeks and 1 year. Pooled data based on the Zurich Claudication Questionnaire of the RCTs were more in favor of IPD treatment compared with conservative treatment (pooled estimate 23.2, SD 18.5-27.8). Statistical heterogeneity after pooled data was low (I-squared 0.0, p = 0.930). Overall complication rate was 7%. CONCLUSION: As the evidence is relatively low and the costs are high, more thorough (cost-) effectiveness studies should be performed before worldwide implementation is introduced.

Background Patients with cervical radicular syndrome due to disc herniation refractory to conservative treatment are offered surgical treatment. Anterior cervical discectomy is the standard procedure, often in combination with interbody fusion. Accelerated adjacent disc degeneration is a known entity on the long term. Recently, cervical disc prostheses are developed to maintain motion and possibly reduce the incidence of adjacent disc degeneration. A comparative cost-effectiveness study focused on adjacent segment degeneration and functional outcome has not been performed yet. We present the design of the NECK trial, a randomised study on cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in patients with cervical disc herniation. Methods/Design Patients (age 18-65 years) presenting with radicular signs due to single level cervical disc herniation lasting more than 8 weeks are included. Patients will be randomised into 3 groups: anterior discectomy only, anterior discectomy with interbody fusion, and anterior discectomy with disc prosthesis. The primary outcome measure is symptomatic adjacent disc degeneration at 2 and 5 years after surgery. Other outcome parameters will be the Neck Disability Index, perceived recovery, arm and neck pain, complications, re-operations, quality of life, job satisfaction, anxiety and depression assessment, medical consumption, absenteeism, and costs. The study is a randomised prospective multicenter trial, in which 3 surgical techniques are compared in a parallel group design. Patients and research nurses will be kept blinded of the allocated treatment for 2 years. The follow-up period is 5 years. Discussion Currently, anterior cervical discectomy with fusion is the golden standard in the surgical treatment of cervical disc herniation. Whether additional interbody fusion or disc prothesis is necessary and cost-effective will be determined by this trial. Trial Registration Netherlands Trial Register NTR1289

Background Decompressive laminotomy is the standard surgical procedure in the treatment of patients with canal stenosis related intermittent neurogenic claudication. New techniques, such as interspinous process implants, claim a shorter hospital stay, less post-operative pain and equal long-term functional outcome. A comparative (cost-) effectiveness study has not been performed yet. This protocol describes the design of a randomized controlled trial (RCT) on (cost-) effectiveness of the use of interspinous process implants versus conventional decompression surgery in patients with lumbar spinal stenosis. Methods/Design Patients (age 40-85) presenting with intermittent neurogenic claudication due to lumbar spinal stenosis lasting more than 3 months refractory to conservative treatment, are included. Randomization into interspinous implant surgery versus bony decompression surgery will take place in the operating room after induction of anesthesia. The primary outcome measure is the functional assessment of the patient measured by the Zurich Claudication Questionnaire (ZCQ), at 8 weeks and 1 year after surgery. Other outcome parameters include perceived recovery, leg and back pain, incidence of re-operations, complications, quality of life, medical consumption, absenteeism and costs. The study is a randomized multi-institutional trial, in which two surgical techniques are compared in a parallel group design. Patients and research nurses are kept blinded of the allocated treatment during the follow-up period of 1 year. Discussion Currently decompressive laminotomy is the golden standard in the surgical treatment of lumbar spinal stenosis. Whether surgery with interspinous implants is a reasonable alternative can be determined by this trial. Trial register Dutch Trial register number: NTR1307

Background The usual surgical treatment of refractory sciatica caused by lumbar disc herniation, is open discectomy. Minimally invasive procedures, including percutaneous therapies under local anesthesia, are increasingly gaining attention. One of these treatments is Percutaneous Laser Disc Decompression (PLDD). This treatment can be carried out in an outpatient setting and swift recovery and return to daily routine are suggested. Thus far, no randomized trial into cost-effectiveness of PLDD versus standard surgical procedure has been performed. We present the design of a randomized controlled trial, studying the cost-effectiveness of PLDD versus conventional open discectomy in patients with sciatica from lumbar disc herniation. Methods/design The study is a randomized prospective multi-center trial, in which two treatment strategies are compared in a parallel group design. Patients (age 18–70 years) visiting the neurosurgery department of the participating hospitals, are considered for inclusion in the trial when sciatica due to lumbar disc herniation has lasted more than 8 weeks. Patients with disc herniation smaller than 1/3 of the spinal canal diameter, without concomitant lateral recess stenosis or sequestration, are eligible for participation, and are randomized into one of two treatment arms; either Percutaneous Laser Disc Decompression or conventional discectomy. The functional outcome of the patient, as assessed by the Roland Disability Questionnaire for Sciatica at 8 weeks and 1 year after treatment, is the primary outcome measure. The secondary outcome parameters are recovery as perceived by the patient, leg and back pain, incidence of re-intervention, complications, quality of life, medical consumption, absence of work and secondary costs. Discussion Open discectomy is still considered to be the golden standard in the surgical treatment of lumbar disc herniation. Whether Percutaneous Laser Disc Decompression has at least as much efficacy as the standard surgical procedure, and is more cost-effective, will be determined by this trial. Trial registration Current Controlled Trials ISRCTN25884790.

Surgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies, baseline data of 283 patients enrolled in a randomized trial, comparing early surgery with prolonged conservative care, were used to analyse effect modification of the allotted treatment strategy. For predictors shown to modify the effect of the treatment strategy, repeated measurement analyses with the Roland Disability Questionnaire and visual analogue scale pain as continuous outcomes were performed for every level of that predictor. Presumed predictive variables did not have any interaction with treatment, while “sciatica provoked by sitting” showed to be a significant effect modifier (P = 0.07). In a Cox model we estimated a hazard ratio (HR, surgery versus conservative) of 2.2 (95% CI 1.7–3.0) in favour of surgery when sciatica was provoked by sitting, while the HR was 1.3 (95% CI 0.8–2.2) when this sign was absent. The interaction effect is marginally significant (interactions are usually tested at the 10% level) but the patterns generated by the repeated measurement analyses of all primary outcomes are completely consistent with the inferred pattern from the survival analysis. Classical signs did not show any contribution as decision support tools in deciding when to operate for sciatica, whereas treatment effects of early surgery are emphasized when sciatica is provoked by sitting and negligible when this symptom is absent.

Background Open discectomy is the standard surgical procedure in the treatment of patients with long-lasting sciatica caused by lumbar disc herniation. Minimally invasive approaches such as microendoscopic discectomy have gained attention in recent years. Reduced tissue trauma allows early ambulation, short hospital stay and quick resumption of daily activities. A comparative cost-effectiveness study has not been performed yet. We present the design of a randomised controlled trial on cost-effectiveness of microendoscopic discectomy versus conventional open discectomy in patients with lumbar disc herniation. Methods/Design Patients (age 18–70 years) presenting with sciatica due to lumbar disc herniation lasting more than 6–8 weeks are included. Patients with disc herniation larger than 1/3 of the spinal canal diameter, or disc herniation less than 1/3 of the spinal canal diameter with concomitant lateral recess stenosis or sequestration, are eliglible for participation. Randomisation into microendoscopic discectomy or conventional unilateral transflaval discectomy will take place in the operating room after induction of anesthesia. The length of skin incision is equal in both groups. The primary outcome measure is the functional assessment of the patient, measured by the Roland Disability Questionnaire for Sciatica, at 8 weeks and 1 year after surgery. We will also evaluate several other outcome parameters, including perceived recovery, leg and back pain, incidence of re-operations, complications, serum creatine kinase, quality of life, medical consumption, absenteeism and costs. The study is a randomised prospective multi-institutional trial, in which two surgical techniques are compared in a parallel group design. Patients and research nurses are kept blinded of the allocated treatment during the follow-up period of 2 years. Discussion Currently, open discectomy is the golden standard in the surgical treatment of lumbar disc herniation. Whether microendoscopic discectomy is more cost-effective than unilateral transflaval discectomy has to be determined by this trial.

Nerve root decompression with instrumented fusion is currently most commonly performed in the treatment of patients with spondylolytic spondylolisthesis. The relationship between successful fusion and clinical outcome remains controversial, thereby questioning the necessity of fusion. Nerve root decompression without fusion, i.e. Gill's procedure, might be a less invasive surgical alternative with comparable clinical outcome. The objective of this study is to compare the long-term results of Gills's procedure with data from literature on decompression with fusion, and, moreover, to determine if a future randomised trial is legitimate. We retrospectively reviewed the long-term results of Gill's procedure in patients with grade I or II spondylolytic spondylolisthesis. All patients suffered from leg pain with or without low back pain. No patient had low back pain alone. In 17 patients a bilateral and in 25 patients a unilateral Gill's procedures were performed. The patients were evaluated at three follow-up moments. On moment 1, 38 patients were clinically examined on their last out-patient control (mean follow-up 11 months). On moment 2, 34 patients were interviewed by telephone (mean follow-up 4.4 years). The final long-term follow-up moment 3 (mean follow-up 10.5 years) included a mailed patient-satisfaction questionnaire of 31 patients (response rate 74%). No surgical complication occurred. Ten of the 42 patients were reoperated because of persistent or recurrent radicular pain (mean time interval 2.9 years). Kaplan-Meier analysis showed a disease-free survival rate of 79% at 5 years and 72% at 10 years after the index operation. On the three follow-up moments, the improvement of leg pain was 92, 97 and 88%, respectively. The final long-term follow-up showed 71% good result in terms of patient satisfaction. The Gill's procedure is a less invasive surgical technique in the treatment of patients with leg pain due to low-grade spondylolytic spondylolisthesis. This technique can be considered as an alternative to instrumented fusion in selected cases. Preoperative instability, discectomy at the affected level and neuroforaminal nerve root compression seem to be negative influencing factors, increasing the risk for secondary instrumented surgery. The results of this study justify a randomised trial.

Background Nerve root decompression with instrumented spondylodesis is the most frequently performed surgical procedure in the treatment of patients with symptomatic low-grade spondylolytic spondylolisthesis. Nerve root decompression without instrumented fusion, i.e. Gill's procedure, is an alternative and less invasive approach. A comparative cost-effectiveness study has not been performed yet. We present the design of a randomised controlled trial on cost-effectiveness of decompression according to Gill versus instrumented spondylodesis. Methods/design All patients (age between 18 and 70 years) with sciatica or neurogenic claudication lasting more than 3 months due to spondylolytic spondylolisthesis grade I or II, are eligible for inclusion. Patients will be randomly allocated to nerve root decompression according to Gill, either unilateral or bilateral, or pedicle screw fixation with interbody fusion. The main primary outcome measure is the functional assessment of the patient measured with the Roland Disability Questionnaire for Sciatica at 12 weeks and 2 years. Other primary outcome measures are perceived recovery and intensity of leg pain and low back pain. The secondary outcome measures include, incidence of re-operations, complications, serum creatine phosphokinase, quality of life, medical consumption, costs, absenteeism, work perception, depression and anxiety, and treatment preference. The study is a randomised prospective multicenter trial in which two surgical techniques are compared in a parallel group design. Patients and research nurse will not be blinded during the follow-up period of 2 years. Discussion Currently, nerve root decompression with instrumented fusion is the golden standard in the surgical treatment of low-grade spondylolytic spondylolisthesis, although scientific proof justifying instrumented spondylodesis over simple decompression is lacking. This trial is designed to elucidate the controversy in best surgical treatment of symptomatic patients with low-grade spondylolytic spondylolisthesis.

Background Anterior cervical discectomy with interbody fusion cages is considered the standard surgical procedure in patients with cervical disc herniation. However, PEEK or metal cages have some undesirable imaging characteristics, leading to a search for alternative materials not creating artifacts on images; silicon nitride ceramic. Whether patients treated with silicon nitride ceramic cages have similar functional outcome as patients treated with PEEK cages is not known. We present the design of the CASCADE trial on effectiveness of ceramic cages versus PEEK cages in patients with cervical disc herniation and/or osteophytes. Methods/Design Patients (age 18–75 years) with monoradicular symptoms in one or both arms lasting more than 8 weeks, due to disc herniation and/or osteophytes, are eligible for the trial. The study is designed as a randomized controlled equivalence trial in which patients are blinded to the type of cage for 1 year. The total follow-up period is 2 years. The primary outcome measure is improvement in the Neck and Disability Index (NDI). Secondary outcomes measures include improvement in arm pain and neck pain (VAS), SF-36 and patients' perceived recovery. The final elements of comparison are perioperative statistics including operating time, blood loss, length of hospital stay, and adverse events. Lateral plane films at each follow-up visit and CT scan (at 6 months) will be used to judge fusion and the incidence of subsidence. Based on a power of 90% and assuming 8% loss to follow-up, 100 patients will be randomized into the 2 groups. The first analysis will be conducted when all patients have 1 year of follow-up, and the groups will be followed for 1 additional year to judge stability of outcomes. Discussion While the new ceramic cage has received the CE Mark based on standard compliance and animal studies, a randomized comparative study with the golden standard product will provide more conclusive information for clinicians. Implementation of any new device should only be done after completion of randomized controlled effectiveness trials.