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

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STUDY DESIGN: This was a retrospective study combined with attempted prospective patient contact to collect current data. OBJECTIVE: The purpose of this study was to investigate long-term clinical outcome of patients undergoing lumbar hybrid surgery (total disc replacement (TDR) at one level and fusion at an adjacent level. SUMMARY OF BACKGROUND DATA: Many patients with symptomatic lumbar disc degeneration are affected at more than one level. Lumbar TDR was introduced as a fusion alternative; however, some disc levels are not amenable to TDR and fusion is preferable at such levels. Hybrid surgery was introduced as an option to fusing multiple levels. METHODS: A consecutive series of 305 patients undergoing lumbar hybrid surgery was identified beginning with the first case experience in 2005. Operative and clinical outcome data including visual analog scales (VAS) assessing back and leg pain, Oswestry Disability Index (ODI), and re-operations were collected. The mean follow-up duration was 67.1 months. RESULTS: There were statistically significant improvements (P<0.01) in the mean values of all three clinical outcome measures: VAS back pain scores improved from 6.7 to 3.3; leg pain improved from 4.3 to 2.0; and ODI scores improved from 45.5 to 24.6. There were no significant differences in pain and function scores for patients with minimum 10-year follow-up vs. those with shorter follow-up duration. Re-operation occurred in 16.1% of patients, many of which involved removal of posterior instrumentation at the fusion level (6.2% of study group, 38.8% of re-operations). Re-operation involving the TDR level occurred in 9 patients (2.9%), only 3 of which (1.0%) involved TDR removal/revision. CONCLUSION: This study supports that for many patients with multilevel symptomatic disc degeneration, hybrid surgery is a viable surgical option. Significant improvements were demonstrated in pain and function scores with no diminished improvement in scores among patients with more than 10-year follow-up.

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

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BACKGROUND CONTEXT: The functional goals of cervical disc arthroplasty (CDA) are to restore enough range of motion (ROM) to reduce the risk of accelerated adjacent segment degeneration but limit excessive motion to maintain a biomechanically stable index segment. This motion-range is termed the "Physiological mobility range." Clinical studies report postoperative ROM averaged over all study subjects but they do not report what proportion of reconstructed segments yield ROM in the Physiological mobility range following CDA surgery. PURPOSE: To calculate the proportion of reconstructed segments that yield flexion-extension ROM (FE-ROM) in the Physiological mobility range (defined as 5°-16°) by analyzing the 24-month postoperative data reported by clinical trials of various cervical disc prostheses. STUDY DESIGN/SETTING: Analysis of 24-month postoperative FE-ROM data from clinical trials. PATIENT SAMPLE: Data from 1,173 patients from single-level disc replacement clinical trials of 7 cervical disc prostheses. OUTCOME MEASURES: 24-month postoperative index-level FE-ROM. METHODS: The FE-ROM histograms reported in Food and Drug Administration-Investigational Device Exemption (FDA-IDE) submissions and available for this analysis were used to calculate the frequencies of implanted levels with postoperative FE-ROM in the following motion-ranges: Hypomobile (0°-4°), Physiological (5°-16°), and Hypermobile (≥17°). The ROM histograms also allowed calculation of the average ROM of implanted segments in each of the 3 motion-ranges. RESULTS: Only 762 of 1,173 patients (implanted levels) yielded 24-month postCDA FE-ROM in the physiological mobility range (5°-16°). The proportions ranged from 60% to 79% across the 7 disc-prostheses, with an average of 65.0%±6.2%. Three-hundred and two (302) of 1,173 implanted levels yielded ROM in the 0°-4° range. The proportions ranged from 15% to 38% with an average of 25.7%±8.9%. One-hundred and nine (109) of 1,173 implanted levels yielded ROM of ≥17° with a range of 2%-21% and an average proportion of 9.3%±7.9%. The prosthesis with built-in stiffness due to its nucleus-annulus design yielded the highest proportion (103/131, 79%) of implanted segments in the physiological mobility range, compared to the cohort average of 65% (p<.01). Sixty-five of the 350 (18.6%) discs implanted with the 2 mobile-core designs in this cohort yielded ROM≥17° as compared to the cohort average of 9.3% (109/1,173) (p<.05). At 2-year postCDA, the "hypomobile" segments moved on average 2.4±1.2°, those in the "physiological-mobility" group moved 9.4±3.2°, and the hypermobile segments moved 19.6±2.6°. CONCLUSIONS: Prosthesis design significantly influenced the likelihood of achieving FE-ROM in the physiological mobility range, while avoiding hypomobility or hypermobility (p<.01). Postoperative ROM averaged over all study subjects provides incomplete information about the prosthesis performance - it does not tell us how many implanted segments achieve physiological mobility and how many end up with hypomobility or hypermobility. We conclude that the proportion of index levels achieving postCDA motions in the physiological mobility range (5°-16°) is a more useful outcome measure for future clinical trials.

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STUDY DESIGN: This was a retrospective study with prospective patient contact attempted to collect current data. OBJECTIVE: The purpose was to investigate the incidence and reasons for lumbar total disk replacement (TDR) removal or revision. SUMMARY OF BACKGROUND DATA: A concern regarding lumbar TDR was safety, particularly the need for device removal or revision. This may be particularly important considering removal/revision requires repeat anterior exposure with an increased risk of vascular injury. METHODS: Data were collected for a series of 2141 lumbar TDR patients, beginning with the first case experience in 2000. The mean follow-up was 78.6 months. For each case of device removal/revision, the reason, duration from index surgery, and procedure performed were recorded. RESULTS: Of 2141 patients, 27 (1.26%) underwent TDR removal or revision. Device removal was performed in 24 patients (1.12%), while three patients underwent revision (0.14%). Of the 24 removals, 12 were due to migration and/or loosening, three developed problems post-trauma, two developed lymphocytic reaction to device materials, two had ongoing pain, and there was one case of each: TDR was too large, vertebral body fracture (osteoporosis), lytic lesion, device subsidence and facet arthrosis, and infection seeded from a chest infection 146 months post-TDR. The three revisions were for Core repositioning (technique error), device repositioning after displacement, and core replacement due to wear/failure. With respect to timing, 37.0% of removals/revisions occurred within one-month postimplantation. Of note, 40.7% of removals/revisions occurred in the first 25 TDR cases performed by individual surgeons. There was one significant vascular complication occurring in a patient whose TDR was removed due to trauma. This was also the only patient among 258 with ≥15-year follow-up who underwent removal/revision. CONCLUSION: In this large consecutive series, 1.26% of TDRs were removed/revised. The low rate over a 20 year period supports the safety of these devices.

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

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BACKGROUND: Anterior lumbar interbody fusion (ALIF) has been performed for many years. Often, posterior supplemental fixation has been used to provide additional stability to the operated segment. Interbody implants have evolved to incorporate unique designs, polyetheretherketone, integrated screws, and surface texture. With these changes, the need for supplemental posterior fixation has been debated. The purpose of this study was to evaluate the clinical outcome of stand-alone ALIF. METHODS: A surgery log was reviewed to identify the consecutive series of 58 patients undergoing ALIF using a STALIF stand-alone cage from March 2011 (first case) to December 2018 (minimum 24 months postoperative) with a mean follow-up of 30.6 months. All patients were treated for symptomatic degenerative conditions. Charts were reviewed to collect general patient information, operative data, and patient-reported outcomes, including the Oswestry Disability Index (ODI), visual analog scales (VAS) separately assessing back pain and leg pain, and re-operations. For patients who were not seen recently in clinic for follow-up, current outcome data were collected through mailings. RESULTS: The mean operative blood loss was 52.1 mL. There was a statistically significant improvement in mean ODI scores from 41.7 preoperatively to 21.0 at follow-up (P < 0.01). There was also significant improvement (P < 0.01) in VAS back pain (6.0-2.5) and leg pain (4.1-1.3). Subsequent surgery was performed on 9 patients. Reasons for re-operation were pseudoarthrosis (n = 3), progressive cage subsidence (n = 1), foraminal stenosis at the index level (n = 1), metal allergy reaction (n = 2), adjacent segment degeneration (n = 1), and ongoing pain (n = 1). There were no cases of device failure, vertebral body fracture, or screws backing out of the implant. DISCUSSION: Stand-alone ALIF was associated with statistically significant improvements in ODI scores, back pain, and leg pain. The re-operation rate for clear pseudoarthrosis or cage subsidence was 6.8%. These results support that stand-alone ALIF produces good outcomes in patients treated for symptomatic disc degeneration while avoiding the use of posterior fixation and its complication risk and cost. CLINICAL RELEVANCE: The results of this study support that stand-alone ALIF is a viable procedure for the treatment of symptomatic disc degeneration unresponsive in patients who have failed nonoperative care and who do not have specific indications for supplemental posterior instrumentation.

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

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BACKGROUND: Cervical artificial disc replacement (C-ADR) has become a common and accepted surgical treatment for many patients with cervical disc degeneration/herniation and radiculopathy who have failed nonoperative treatment. Midterm follow-up studies of the original investigational device exemption trials comparing C-ADR to traditional anterior cervical discectomy and fusion (ACDF) have revealed C-ADR patients have less adjacent-level disease and fewer reoperations at 5 to 7 years. The purpose of this study was to examine the relationship of radiographic adjacent-level disease (R-ALD) with the amount of index-level segmental range of motion (ROM) in C-ADR patients using the long-term follow-up data from the ProDisc-C investigational device exemption trial. METHODS: This was a post hoc analysis of a 1:1 randomized controlled trial. The initial previously described Food and Drug Administration-approved 2-year study was extended, and consenting patients in the original study were followed at annual intervals up to 7 years. Logistic regression was used to assess any progression in adjacent-level disease (ALD). Ordinal logistic regression was also used to assess the relationship between any progressive R-ALD and final flexion extension (F/E) ROM in C-ADR patients. Spearman's rank-order correlation was used when R-ALD was kept as an ordinal variable to assess the same relationship. RESULTS: At the last follow-up visit, the rate of progressive R-ALD was significantly higher in ACDF patients than in C-ADR patients. When C-ADR patients were divided into 3 groups based on final F/E ROM, those with 0° to 3° (n = 19), 4° to 6° (n = 15), and 7° (n = 42) of segmental motion at the index procedure level, the rate of progressive R-ALD trended significantly with final ROM (P = 0.01). CONCLUSIONS: C-ADR leads to a significant decrease in R-ALD compared to ACDF. The difference in R-ALD is related to the preservation of motion at the index level and resultant preservation of kinematics and forces across the adjacent disc space.

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Biomechanical studies have demonstrated that cervical fusion results in increased motion and intradiscal pressures at adjacent levels. Cervical disc arthroplasty (CDA) is an alternative treatment for cervical radiculopathy and myelopathy resulting from degenerative disc disease. By maintaining segmental motion, surgeons hope to avoid some of the primary drawbacks of anterior cervical discectomy and fusion (ACDF), such as pseudoarthrosis and adjacent segment disease. First introduced in the 1960s, CDA has evolved over the years with changes to implant geometry and materials. Early devices produced suboptimal outcomes, but more recent generations of implants have shown long-term outcomes rivaling or even surpassing those of ACDF. In this article, the rationale for CDA as well as the history of such devices is reviewed.

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INTRODUCTION: One important factor in evaluating the safety of an implant is the rate of subsequent surgery and the reasons for surgery, particularly those that are related to possible problems with the implant. The purpose of this study was to determine the overall re-operation rate (including revisions, removals, device-related, procedure-related, adjacent segment, and others) for a large consecutive series of cervical TDR patients beginning with the first case experience, using a single device at a single institution. METHODS: Surgery records were reviewed to identify cervical TDR patients and those who underwent subsequent surgery. Cervical TDR cases involving ProDisc-C were identified, beginning with the first case performed in 2003 at a multisite spine specialty centre. Only patients who were at least 2 years post-operative were included, producing a consecutive series of 535 patients. There were 115 hybrids in the series (TDR at one level and fusion at an adjacent segment). Data collected included general demographics and level(s) operated. A surgery log through 12-31-18 was reviewed to identify re-operations occurring in the TDR patients. For each re-operation, the reason, duration from index surgery, and procedure were recorded. The mean duration from the index surgery to the search of the surgery log for re-operations was 78.3 months, range 24 to 181 months. RESULTS: Re-operation occurred in 30 patients (5.6%). These included: 3 TDR removals and revision to anterior discectomy and fusion (1 for migration, 1 for subsidence, and 1 for spondylosis), 1 TDR repositioning, 21 secondary surgeries for adjacent segment degeneration (5 of which were adjacent to fusion levels in hybrid procedures), 1 wound infection, 1 hematoma, and 2 received stimulators for pain control. There were no re- operations for device failure. In cases of re-operation for adjacent segment degeneration, the mean duration between the index surgery and re-operation was 47.3 months. CONCLUSION: The re-operation rate was 5.6%. No surgeries were performed for device failure. These results support the safety of the TDR device.

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STUDY DESIGN: Systematic literature review with meta-analysis. OBJECTIVE: Osteoporosis is common in elderly patients, who frequently suffer from spinal fractures or degenerative diseases and often require surgical treatment with spinal instrumentation. Diminished bone quality impairs primary screw purchase, which may lead to loosening and its sequelae, in the worst case, revision surgery. Information about the incidence of spinal instrumentation-related complications in osteoporotic patients is currently limited to individual reports. We conducted a systematic literature review with the aim of quantifying the incidence of screw loosening in osteoporotic spines. METHODS: Publications on spinal instrumentation of osteoporotic patients reporting screw-related complications were identified in 3 databases. Data on screw loosening and other local complications was collected. Pooled risks of experiencing such complications were estimated with random effects models. Risk of bias in the individual studies was assessed with an adapted McHarm Scale. RESULTS: From 1831 initial matches, 32 were eligible and 19 reported screw loosening rates. Studies were heterogeneous concerning procedures performed and risk of bias. Screw loosening incidences were variable with a pooled risk of 22.5% (95% CI 10.8%-36.6%, 95% prediction interval [PI] 0%-81.2%) in reports on nonaugmented screws and 2.2% (95% CI 0.0%-7.2%, 95% PI 0%-25.1%) in reports on augmented screws. CONCLUSIONS: The findings of this meta-analysis suggest that screw loosening incidences may be considerably higher in osteoporotic spines than with normal bone mineral density. Screw augmentation may reduce loosening rates; however, this requires confirmation through clinical studies. Standardized reporting of prespecified complications should be enforced by publishers.

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PURPOSE: The purpose was to investigate reasons and their frequency for why total disc replacement (TDR) specialty surgeons performed anterior cervical discectomy and fusion (ACDF) rather than TDR. METHODS: A consecutive series of 464 patients undergoing cervical spine surgery during a 5-year period by three TDR specialty surgeons was reviewed. For each ACDF, the reason for not performing TDR was recorded. RESULTS: TDR was performed in 76.7% of patients (n = 356) and ACDF in 23.3% (n = 108). The most common reason for ACDF versus TDR was anatomical (conditions that may not be adequately addressed with TDR and/or may interfere with device function), which occurred in 64 of 464 patients (13.79%). The second most common reason was insurance (denial/lack of coverage n = 17, 3.23%), and deformity/kyphosis not addressable with TDR was noted in 13 (2.80%). Pseudoarthrosis repair led to ACDF in three patients (0.65%), two did not receive TDR due to osteoporosis (0.43%), and in two others (0.43%) ACDF was undertaken due to high risk of heterotopic ossification. There was one case (0.22%) each of: nickel allergy, trauma with posterior element fracture, TDR removal, multiple prior cervical spine surgeries, concern about artifact on future imaging studies, benign osteoblastic bone, and limitation to adequate surgical approach for TDR. ACDF patients' mean age was significantly greater than TDR patients' (55.3 vs. 46.7 years; p < 0.01). TDR group had significantly more single-level procedures than ACDF (60.8% vs. 43.5%; p < 0.05). CONCLUSION: The most common reason for ACDF versus TDR was anatomy that may compromise segmental stability and/or TDR functionality. Older age and greater number of operated levels may be related to anatomical factors, primarily significant osteophytes and severely degenerated facets. These factors, as well as deformity/kyphosis, are more common in older patients and require multi-level treatment. This study found that many patients are good cervical TDR candidates; however, even among TDR specialists, ACDF may be preferred where it is prudent to not take undue risks. These slides can be retrieved under Electronic Supplementary Material.

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STUDY DESIGN: Post-hoc analysis of 5-year follow-up data from a randomized, multicenter trial. OBJECTIVE: The aim of this study was to investigate the incidence of progression in radiographic adjacent-level degeneration (ΔALD) from preoperative assessment to 5 years after total disc replacement (TDR) and the relationship of these changes with range of motion and clinical adjacent-level disease. A secondary objective was to compare adjacent-level degeneration (ALD) outcomes between TDR and fusion. SUMMARY OF BACKGROUND DATA: Fusion is associated with high rates of ALD in symptomatic lumbar disc degeneration. TDR may reduce this risk. METHODS: In total, 175 patients with single-level, symptomatic, lumbar disc degeneration who had received activL or ProDisc-L and had a preoperative and 5-year postoperative radiograph available were included. Over 5-year follow-up, ΔALD was defined as an increase in ALD of ≥1 grade and clinical ALD was defined as surgical treatment at the level adjacent to an index TDR. Matching-adjusted indirect comparisons were conducted to compare ALD outcomes after TDR (current trial) with those after fusion (published trial). RESULTS: At 5-year follow-up, 9.7% (17/175) of TDR patients had ΔALD at the superior level. In patients with preoperative ALD at the superior level, most (88% [23/26]) showed no radiographic progression over 5 years. The rate of clinical ALD was 2.3% (4/175) and none of these patients had ALD at baseline. For each degree of range of motion gained at the TDR level, there was a consistent decrease in the percentage of patients with ΔALD. After matching and adjustment of baseline characteristics, TDR had a significantly lower likelihood of ΔALD than fusion (odds ratio 0.32; 95% confidence interval 0.13, 0.76). CONCLUSION: The rates of ΔALD and clinical ALD in this TDR population were similar to those previously reported in the literature for TDR at 5-year follow-up. TDR had a significantly lower rate of ΔALD than fusion. LEVEL OF EVIDENCE: 3.

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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.

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STUDY DESIGN: This study represents a posthoc analysis of data collected from 2 control arms of a prospective, randomized study. OBJECTIVE: The purpose of this study was to compare results of patients undergoing 1- versus 2-level anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA: For single-level ACDF, reported outcomes have generally been good; however, results for 2 levels have been less consistent. METHODS: This 60-month follow-up study was based on data from the prospective Food and Drug Administration regulated Mobi-C artificial disc trial. Serving as the control, ACDF was performed at 1 level in 81 patients and 2 levels in 105 patients. Study selection criteria, fusion technique, and outcome measures were identical, with the only exception being the number of levels that were pathological and operated. RESULTS: Neck Disability Index (NDI) scores, visual analog scales assessing neck and arm pain, and SF-12 scores improved significantly in both groups. Significant differences were observed between groups on NDI and SF-12 PCS scores through 60 months. Fusion rates were 93.3% in the 1-level group and 86.1% in the 2-level (60 months, not significantly different). Adjacent segment degeneration occurred in 54.7% of patients at the superior level and 44.7% at the inferior segment in the 1-level group and 70.8%, and 55.0% respectively in 2-level patients (trend at superior level; 0.05 < P < 0.10). Subsequent index level surgery was performed in 11.1% of single-level patients versus 16.2% of the 2-level group (not significantly different). CONCLUSION: One- and 2-level ACDF groups improved significantly and maintained improvement throughout 60 month follow-up. When comparing groups, outcomes were often similar, though the 1-level group demonstrated higher fusion rates at 6 and 12 months, greater improvement in NDI scores from 18 to 60-month follow-up, and greater improvement in SF-12 PCS from 12 to 60 months.

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INTRODUCTION: If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression. The purpose of this study was to investigate 5-year outcomes associated with an interlaminar device. METHODS: This prospective, randomized, controlled trial was conducted at 21 centers. Patients with moderate to severe lumbar stenosis at one or two contiguous levels and up to Grade I spondylolisthesis were randomized (2:1 ratio) to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex(®) Interlaminar Stabilization(®) device (Paradigm Spine, LLC) or decompression and fusion with pedicle screws (D+PS; n=107). Clinical evaluations were made preoperatively and at 6 weeks and 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively. Overall Food and Drug Administration success criteria required that a patient meet 4 criteria: 1) >15 point improvement in Oswestry Disability Index (ODI) score; 2) no reoperation, revision, removal, or supplemental fixation; 3) no major device-related complication; and 4) no epidural steroid injection after surgery. RESULTS: At 5 years, 50.3% of D+ILS vs. 44% of D+PS patients (p>0.35) met the composite success criteria. Reoperation/revision rates were similar in the two groups (16.3% vs. 17.8%; p >0.90). Both groups had statistically significant improvement through 60 months in ODI scores with 80.6% of D+ILS patients and 73.2% of D+PS patients demonstrating >15 point improvement (p>0.30). VAS, SF-12, and ZCQ scores followed a similar pattern of maintained significant improvement throughout follow-up. On the SF-12 and ZCQ, D+ILS group scores were statistically significantly better during early follow-up compared to D+PS. In the D+ILS group, foraminal height, disc space height, and range of motion at the index level were maintained through 5 years. CONCLUSION: Both treatment groups achieved and maintained statistically significant improvements on multiple outcome assessments throughout 5-year follow-up. On some clinical measures, there were statistically significant differences during early follow-up favoring D+ILS. At no point were there significant differences favoring D+PS. Results of this 5-year follow-up study demonstrate that decompression and interlaminar stabilization with coflex is a viable alternative to traditional decompression and fusion in the treatment of patients with moderate to severe stenosis at one or two lumbar levels. LEVEL OF EVIDENCE AND ETHICAL STATEMENTS: This is a Level I study. Institutional approval was received at each of the sites participating in the trial. Each patient gave informed consent to participate in the trial.

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OBJECTIVE The purpose of this study was to evaluate the 7-year cost-effectiveness of cervical total disc replacement (CTDR) versus anterior cervical discectomy and fusion (ACDF) for the treatment of patients with single-level symptomatic degenerative disc disease. A change in the spending trajectory for spine care is to be achieved, in part, through the selection of interventions that have been proven effective yet cost less than other options. This analysis complements and builds upon findings from other cost-effectiveness evaluations of CTDR through the use of long-term, patient-level data from a randomized study. METHODS This was a 7-year health economic evaluation comparing CTDR versus ACDF from the US commercial payer perspective. Prospectively collected health care resource utilization and treatment effects (quality-adjusted life years [QALYs]) were obtained from individual patient-level adverse event reports and SF-36 data, respectively, from the randomized, multicenter ProDisc-C total disc replacement investigational device exemption (IDE) study and post-approval study. Statistical distributions for unit costs were derived from a commercial claims database and applied using Monte Carlo simulation. Patient-level costs and effects were modeled via multivariate probabilistic analysis. Confidence intervals for 7-year costs, effects, and net monetary benefit (NMB) were obtained using the nonparametric percentile method from results of 10,000 bootstrap simulations. The robustness of results was assessed through scenario analysis and within a parametric regression model controlling for baseline variables. RESULTS Seven-year follow-up data were available for more than 70% of the 209 randomized patients. In the base-case analysis, CTDR resulted in mean per-patient cost savings of $12,789 (95% CI $5362-$20,856) and per-patient QALY gains of 0.16 (95% CI -0.073 to 0.39) compared with ACDF over 7 years. CTDR was more effective and less costly in 90.8% of probabilistic simulations. CTDR was cost-effective in 99.8% of sensitivity analysis simulations and generated a mean incremental NMB of $20,679 (95% CI $6053-$35,377) per patient at a willingness-to-pay threshold of $50,000/QALY. CONCLUSIONS Based on this modeling evaluation, CTDR was found to be more effective and less costly over a 7-year time horizon for patients with single-level symptomatic degenerative disc disease. These results are robust across a range of scenarios and perspectives and are intended to support value-based decision making.

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BACKGROUND: In patients with single-level cervical degenerative disc disease, total disc arthroplasty can relieve radicular pain and preserve functional motion between two vertebrae. We compared the efficacy and safety of cervical total disc arthroplasty with that of anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical degenerative disc disease between C3-C4 and C6-C7. METHODS: Two hundred and nine patients at thirteen sites were randomly treated with either total disc arthroplasty with ProDisc-C (n = 103) or with ACDF (n = 106). Patients were assessed preoperatively; at six weeks and three, six, twelve, eighteen, and twenty-four months postoperatively; and then annually until seven years postoperatively. Outcome measures included the Neck Disability Index (NDI), the Short Form-36 (SF-36), postoperative neurologic parameters, secondary surgical procedures, adverse events, neck and arm pain, and satisfaction scores. RESULTS: At seven years, the overall follow-up rate was 92% (152 of 165). There were no significant differences in demographic factors, follow-up rate, or patient-reported outcomes between groups. Both procedures were effective in reducing neck and arm pain and improving and maintaining function and health-related quality of life. Neurologic status was improved or maintained in 88% and 89% of the patients in the ProDisc-C and ACDF groups, respectively. After seven years of follow-up, thirty secondary surgical procedures had been performed in nineteen (18%) of 106 patients in the ACDF group compared with seven secondary surgical procedures in seven (7%) of 103 patients in the ProDisc-C group (p = 0.0099). There were no significant differences in the rates of any device-related adverse events between the groups. CONCLUSIONS: Total disc arthroplasty with ProDisc-C is a safe and effective surgical treatment of single-level symptomatic cervical degenerative disc disease. Clinical outcomes after total disc arthroplasty with ProDisc-C were similar to those after ACDF. Patients treated with ProDisc-C had a lower probability of subsequent surgery, suggesting that total disc arthroplasty provides durable results and has the potential to slow the rate of adjacent-level disease. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

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