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Abstract BACKGROUND Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration. OBJECTIVE To report the 10-yr outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology. METHODS This was a prospective study of patients treated with CDA at 1 or 2 contiguous levels using the Mobi-C® Cervical Disc (Zimmer Biomet). Following completion of the 7-yr Food and Drug Administration postapproval study, follow-up continued to 10 yr for consenting patients at 9 high-enrolling centers. Clinical and radiographic endpoints were collected out to 10 yr. RESULTS At 10 yr, patients continued to have significant improvement over baseline Neck Disability Index (NDI), neck and arm pain, neurologic function, and segmental range of motion (ROM). NDI and pain outcomes at 10 yr were significantly improved from 7 yr. Segmental and global ROM and sagittal alignment also were maintained from 7 to 10 yr. Clinically relevant adjacent segment pathology was not significantly different between 7 and 10 yr. The incidence of motion restricting heterotopic ossification at 10 yr was not significantly different from 7 yr for 1-level (30.7% vs 29.6%) or 2-level (41.7% vs 39.2%) patients. Only 2 subsequent surgeries were reported after 7 yr. CONCLUSION Our results through 10 yr were comparable to 7-yr outcomes, demonstrating that CDA with Mobi-C continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease. Graphical Abstract Graphical Abstract

Despite being considered the standard surgical procedure for symptomatic cervical disc disease, anterior cervical decompression and fusion invariably accelerates adjacent segment degeneration. Cervical total disc replacement is a motion-preserving procedure developed as a substitute to fusion. Whether cervical total disc replacement is superior to fusion remains unclear. We comprehensively searched PubMed, EMBASE, Medline, and the Cochrane Library in accordance with the inclusion criteria to identify possible studies. The retrieved results were last updated on December 12, 2014. We classified the studies as short-term and midterm follow-up. Nineteen randomized controlled trials involving 4516 cases were identified. Compared with anterior cervical decompression and fusion, cervical total disc replacement had better functional outcomes (neck disability index [NDI], NDI success, neurological success, neck pain scores reported on a numerical rating scale [NRS], visual analog scales scores and overall success), greater segmental motion at the index level, fewer adverse events and fewer secondary surgical procedures at the index and adjacent levels in short-term follow-up (P < 0.05). With midterm follow-up, the cervical total disc replacement group indicated superiority in the NDI, neurological success, pain assessment (NRS), and secondary surgical procedures at the index level (P < 0.05). The Short Form 36 (SF-36) and segmental motion at the adjacent level in the short-term follow-up showed no significant difference between the two procedures, as did the secondary surgical procedure rates at the adjacent level with midterm follow-up (P > 0.05). Cervical total disc replacement presented favorable functional outcomes, fewer adverse events, and fewer secondary surgical procedures. The efficacy and safety of cervical total disc replacement are superior to those of fusion. Longer-term, multicenter studies are required for a better evaluation of the long-term efficacy and safety of the two procedures.

To investigate the efficacy of adding supplemental fusion or arthroplasty after cervical anterior discectomy for symptomatic mono-level cervical degenerative disease (radiculopathy), which has not been substantiated in controlled trials until now. A randomized controlled trial is reported with 9 years follow up comparing anterior cervical anterior discectomy without fusion, with fusion by cage standalone, or with disc prosthesis. Patients suffering from symptomatic cervical disk degeneration at one level referred to spinal sections of department of neurosurgery or orthopedic surgery of a large general hospital with educational facilities were eligible. Neck Disability Index (NDI), McGill Pain Questionnaire Dutch language version (MPQ-DLV), physical-component summary (PCS), and mental-component summary (MCS) of the 36-item Short-Form Health Survey (SF-36), and re operation rate were evaluated. 142 patients between 18 and 55 years were allocated. The median follow-up was 8.9±1.9 years (5.6 to 12.2 years). The response rate at last follow-up was 98.5%. NDI at the last follow-up did not differ between the three treatment groups, nor did the secondary outcomes as MPQ-DLV and PCS or MCS from SF-36. The major improvement occurred within the first 6 weeks after surgery. Afterward, it remained stable. Eleven patients underwent surgery for recurrent symptoms and signs due to nerve root compression at the index or adjacent level. This randomized trial could not detect a difference between three surgical modalities for treating a single-level degenerative disk disease. Anterior cervical discectomy without implant seems to be similar to anterior cervical discectomy with fusion by cage stand-alone or with disk prosthesis. Due to the small study sample size, this statement should be considered as inconclusive so far. ISRCTN41681847.

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

Purpose Previous studies have demonstrated that total cervical disc replacement (cTDR) represents a viable treatment alternative to the ‘gold standard’ anterior cervical discectomy and fusion for the treatment of well-defined cervical pathologies at short- and mid-term follow-up (FU). However, the implementation and acceptance of a non-fusion philosophy is closely associated with its avoidance of adjacent segment degeneration. Proof of the functional sustainability and clinical improvement of symptoms at long-term FU is still pending. The aim of this ongoing prospective study was to investigate the clinical and radiological results of cTDR at long-term FU. Methods 50 patients were treated surgically within a non-randomised prospective study framework with cTDR (ProDisc C™, Synthes, Paoli, PA, USA). Patients were examined preoperatively followed by routine clinical and radiological examinations at 1, 5 and 10 years after surgery, respectively. In addition to the clinical scores, conventional X-ray images of the cervical spine were taken in anteroposterior and lateral view as well as flexion/extension images. Clinical outcome scores included parameters such as the Neck Disability Index (NDI), Visual Analogue Scale (VAS), arm and neck pain self-assessment questionnaires as well as subjective patient satisfaction rates. The radiological outcome variables included the range of motion (ROM) of the implanted prosthesis between maximum flexion and extension images, the occurrence of heterotopic ossifications and radiographic signs of adjacent segment degenerative changes. The reoperation rate following cTDR was recorded as a secondary outcome variable. Results A significant and maintained clinical improvement of all clinical outcome scores was observed after a mean FU of 10.2 years (VASarm 6.3–2.1; VASneck 6.4–1.9; NDI 21–6; p  < 0.05). An increase in the incidence and the extent of heterotopic ossifications was noted during the post-operative course with a significant influence on the function of the prosthesis, which, however, did not reveal any detrimental effect on the patients’ clinical symptomatology. Prosthesis mobility declined from 9.0° preoperatively and 9.1° at 1 year FU to 7.7° and 7.6° at the five- and ten-year FU examinations, respectively. Radiological signs of adjacent segment degeneration were detected in 13/38 (35.7%), however, in only 3/38 (7.9%) patients this radiological changes were associated with clinical symptoms requiring conservative treatment. Intraoperative technical failure in two cases required interbody fusion with a cage (2/50). One patient (1/48, 2.1%) treated this motion device had revision surgery at the index level. Conclusion Cervical total disc replacement with ProDisc C demonstrated a significant and maintained improvement of all clinical outcome parameters at a follow-up of ≥10 years. The present long-term data reveal that with an exceptionally low implant-related reoperation rate and low symptomatic adjacent segment degeneration rate, cTDR may be regarded as a safe and viable treatment option.

Purpose The objective of this trial was to compare the safety and efficacy of TDA using the ProDisc-C implant to ACDF in patients with single-level SCDD between C3 and C7. Methods We report on the single-site results from a larger multicenter trial of 13 sites using an approved US Food and Drug Administration protocol (prospective, randomized controlled non-inferiority design). Patients were randomized one-to-one to either the ProDisc-C device or ACDF. All enrollees were evaluated pre- and post-operatively at regular intervals through month 84. Visual Analog Scale (VAS) for neck and arm pain/intensity, Neck Disability Index (NDI), Short-Form 36 (SF-36), and satisfaction were assessed. Results Twenty-two patients were randomized to each arm of the study. Nineteen additional patients received the ProDisc-C via continued access. NDI improved with the ProDisc-C more than with ACDF. Total range of motion was maintained with the ProDisc-C, but diminished with ACDF. Neck and arm pain improved more in the ProDisc-C than ACDF group. Patient satisfaction remained higher in the ProDisc-C group at 7 years. SF-36 scores were higher in the TDA group than ACDF group at 7 years; the difference was not clinically significant. Six additional operations (two at the same level; four at an adjacent level) were performed in the ACDF, but none in the ProDisc-C group. Conclusions The ProDisc-C implant appears to be safe and effective for the treatment of SCDD. Patients with the implant retained motion at the involved segment and had a lower reoperation rate than those with an ACDF.

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

•There is significant improvement in clinical outcomes at 24 months postoperation.•Segmental motion and disc height of skip level are preserved with low complications.•Success of multilevel ACDR is an important foundation for the treatment of SCDDD.•Security and low morbidity of Prestige-LP is another basis for the treatment of SCDDD.•Cervical disc replacement is an option for skip cervical degenerative disc disease. We describe the features of non-contiguous 2-level cervical degenerative disc disease (NCDDD), investigate the safety and feasibility of artificial cervical disc replacement (ACDR) for the treatment of NCDDD, and expect that our study will provide spine surgeons with an alternative procedure for NCDDD. Twenty-five patients with NCDDD received ACDR with a Prestige-LP prosthesis. Clinical outcomes were evaluated using the 36-Short Form (SF-36, Mental Component Summary [MCS] and Physical Component Summary [PCS]), Visual Analog Scale (VAS), Japanese Orthopedic Association (JOA), and Neck Disability Index (NDI) scores. Radiographic evaluations included cervical lordosis (CL), range of motion (ROM), and disc height (DH). Data regarding complications were collected as well. The mean follow-up period was 32.24 months. Clinical outcomes, including SF-36 MCS and PCS, VAS, JOA, and NDI scores significantly improved at the 24-month follow-up (p<0.05). There were no significant differences in CL and ROM at the 24-month follow-up (p>0.05). Although there was a significant difference between the before and 3-month follow-up (p<0.05), the ROM of the intermediate segment (IS) showed a tendency of returning to the preoperative state. The DH of the IS was maintained at each measurement while the DH of the upper and lower operated segments significantly increased at the 24-month follow-up (p<0.05). One patient, whose prosthesis remained mobile at the last follow-up, showed evidence of heterotopic ossification (HO). ACDR with the Prestige-LP prosthesis is a safe and feasible alternative procedure for treatment of NCDDD. In the future, a large-sample, prospective randomized controlled study with long-term follow-up will be needed to further demonstrate noncontiguous ACDR as an optimal surgical option for NCDDD.

Objective To quantitatively investigate the effects of Modic-III changes on the porous bone ingrowth at the interface of cervical disc prosthesis using caprine models. Methods The Modic-III changes were induced at C3-4 level in eight goats by discectomy, followed by the implantation of cervical disc prostheses, while another eight goats served as a control group. Computed tomography (CT) and X-rays of cervical spine were performed intraoperatively and postoperatively at verify implant placement. The vertebral specimens were examined by micro-CT for histomorphometric quantification, including bone volume fraction (BV/TV), trabecular number (Tb.N), trabecular thickness (Tb.Th). Methylene-blue/acid fuchsin staining, standard hematoxylin and eosin staining, and Masson staining were used for histologic evaluation. Immunohistochemical staining, including osteocalcin (OCN), alkaline phosphate (ALP), and runt-related transcription factor 2 (RUNX2), were also conducted. Results All goats were followed for a period of 6 months after prosthesis implantation. The rate of prosthesis complications in experimental group was significantly higher than that in control group (37.5% vs. 12.5%, P  = 0.046). The histomorphometric parameters of experimental group, including BV/TV, Tb.N, Tb.Th, and bone ingrowth percentage were significantly lower than those of control group. The histologic sections of control group showed the excellent bone ingrowth and close contact between bone and prosthesis interface. By contrast, in experimental group, plenty of interfacial gaps were filled up with abundant fibrous tissue. The immunohistochemical sections of control group demonstrated the bone trabecula was surrounded by numerous osteoblasts, compared with the clear and smooth bone trabecula margin surrounded by few osteoblasts in experimental group. Moreover, the experimental group had significantly lower integrated optical density values of OCN, ALP, and RUNX2 staining. Conclusion The Modic-III changes significantly impaired the osseointegration of artificial cervical disc in caprine models by reducing the number of osteoblasts, BV/TV, Tb.N, Tb.Th, bone ingrowth percentage and down-regulating the expression levels of ALP, Osteocalcin, and Runx-2, possibly leading to more occurrence of prosthesis complications.

Purpose Cervical total disc replacement (cTDR) has been established as an alternative treatment for degenerative cervical radiculopathy and myelopathy. While the rate of complications for cTDR is reasonably low, recent studies have focused on bone loss after cTDR. The purpose of this work is to develop a clinical management plan for cTDR patients with evidence of bone loss. To guide our recommendations, we undertook a review of the literature and aimed to determine: (1) how bone loss was identified/imaged, (2) whether pre- or intraoperative assessments of infection or histology were performed, and (3) what decision-making and revision strategies were employed. Methods We performed a search of the literature according to PRISMA guidelines. Included studies reported the clinical performance of cTDR and identified instances of cervical bone loss. Results Eleven case studies and 20 cohort studies were reviewed, representing 2073 patients with 821 reported cases of bone loss. Bone loss was typically identified on radiographs during routine follow-up or by computed tomography (CT) for patients presenting with symptoms. Assessments of infection as well as histological and/or explant assessment were sporadically reported. Across all reviewed studies, multiple mechanisms of bone loss were suspected, and severity and progression varied greatly. Many patients were reportedly asymptomatic, but others experienced symptoms like progressive pain and paresthesia. Conclusion Our findings demonstrate a critical gap in the literature regarding the optimal management of patients with bone loss following cTDR, and treatment recommendations based on our review are impractical given the limited amount and quality evidence available. However, based on the authors’ extensive clinical experience, close follow-up of specific radiographic observations and serial radiographs to assess the progression/severity of bone loss and implant changes are recommended. CT findings can be used for clinical decision-making and further follow-up care. The pattern and rate of progression of bone loss, in concert with patient symptomatology, should determine whether non-operative or surgical intervention is indicated. Future studies involving implant retrieval, histopathological, and microbiological analysis for patients undergoing cTDR revision for bone loss are needed.