Mobi-C Cervical Artificial Disc Research Articles

Case control study on Mobi-C cervical artificial disc replacement and anterior cervical decompression MC+fusion for the treatment of cervical spondylosis

To compare the clinical effects and clinical indications between Mobi-C cervical artificial disc replacement (CADR) and MC+ anterior cervical decompression and fusion(ACDF) in treating cervical spondylosis. The clinical data of 100 patients with cervical spondylosis treated ACDF or CADR from June 2009 to June 2015 were retrospectively analyzed. There were 53 males and 47 females, aged from 38 to 70 years old. Among them, 50 cases were treated by ACDF (ACDF group), follow-up time was for 22 to 42 months with an average of (32.24±5.20) months;other 50 cases were treated by CADR (CADR group), follow-up time was for 23 to 48 months with an average of (30.40±5.66) months. Odom criterion was used to evaluate the clinical effects in two groups. JOA score, including sensory function, motor function and bladder function was used to assess the spinal cord function. Preoperative and postoperative responsible intervertebral space heights, cervical curvatures were compared by image data between two groups. All incisions obtained good healing and no serious complications were found. At final follow-up, 30 cases got excellent results, 12 good, 8 fair in ACDF group;and 34 cases got excellent results, 10 good, 6 fair in CADR group;there was no significant difference between two groups(u=4.000, P=0.827). At final follow-up, the scores of sensory function and motor function were obviously improved(P<0.05), and bladder function had not obviously recovered (P>0.05) in two groups;and CADR group in the scores of sensory function and motor function were obviously better than of ACDF group(P<0.05). There was no significant difference in preoperative intervertebral space height, cervical curvature between two groups, and at final follow-up both had different recovered. The recovery of CADR group was obviously better than of ACDF group. CADR can quickly recover normal action for patients and retains the movement. CADR has certain advantages in recovering cervical curvature, improveing sensory function and motor function, but it is not able to completely replace ACDF.

Efficacy and safety of Mobi-C cervical artificial disc versus anterior discectomy and fusion in patients with symptomatic degenerative disc disease: A meta-analysis.

Background:Total disc replacement (TDR) using Mobi-C cervical artificial disc might be promising to treat symptomatic degenerative disc disease. However, the results remained controversial. We conducted a systematic review and meta-analysis to compare the efficacy and safety of Mobi-C cervical artificial disc and anterior cervical discectomy and fusion (ACDF) in patients with symptomatic degenerative disc disease.Methods:PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases were systematically searched. Randomized controlled trials (RCTs) assessing the effect of Mobi-C versus ACDF on the treatment of symptomatic degenerative disc disease were included. Two investigators independently searched articles, extracted data, and assessed the quality of included studies. The primary outcomes were neck disability index (NDI) score, patient satisfaction, and subsequent surgical intervention. Meta-analysis was performed using the random-effect model.Results:Four RCTs were included in the meta-analysis. Overall, compared with ACDF surgery for symptomatic degenerative disc disease, TDR using Mobi-C was associated with a significantly increased NDI score (Std. mean difference = 0.32; 95% CI = 0.10–0.53; P = .004), patient satisfaction (odds risk [OR] = 2.75; 95% confidence interval [CI] = 1.43–5.27; P = .002), and reduced subsequent surgical intervention (OR = 0.20; 95% CI = 0.11–0.37; P < .001). Mobi-C was found to produce comparable neurological deterioration (OR = 0.77; 95% CI = 0.35–1.72; P = .53), radiographic success (OR = 1.18; 95% CI = 0.39–3.59; P = .77), and overall success (OR = 2.13; 95% CI = 0.80–5.70; P = .13) compared with ACDF treatment.Conclusion:Among the 4 included RCTs, 3 articles were studying patients with 1 surgical level, and 1 article reported 2 surgical levels. When compared with ACDF surgery in symptomatic degenerative disc disease, TDR using Mobi-C cervical artificial disc resulted in a significantly improved NDI score, patient satisfaction, and reduced subsequent surgical intervention. There was no significant difference of neurological deterioration, radiographic success, and overall success between TDR using Mobi-C cervical artificial disc versus ACDF surgery. TDR using Mobi-C cervical artificial disc should be recommended for the treatment of symptomatic degenerative disc disease.

Are patient-reported outcomes predictive of patient satisfaction 5 years after anterior cervical spine surgery?

Background ContextPatient satisfaction is becoming an increasing common proxy for surgical quality; however, the correlation between patient satisfaction and surgical outcomes 2 and 5 years after anterior cervical surgery has not been evaluated. PurposeThe study aimed to determine if patient satisfaction is predicted by improvement in patient-reported outcomes (PRO) 2 and 5 years after anterior cervical spine surgery. Study DesignThis is a retrospective analysis of prospectively collected data. Patient SampleThe sample included patients enrolled in the Food and Drug Administration investigational device exemption clinical trial comparing total disc replacement with Mobi-C cervical artificial disc and anterior cervical discectomy and fusion. Outcome MeasuresThe outcome measures were visual analog scale (VAS) neck pain score, Neck Disability Index (NDI), and Short-Form 12-Item scores, as well as patient satisfaction. MethodsReceiver operating characteristic curves were used to determine if improvement in different PRO metrics can accurately identify patient satisfaction. Additionally, a logistic regression analysis was performed on the results at 24 months and 60 months to identify independent predictors of patient satisfaction. This research was supported by LDR (Zimmer Biomet) 13785 Research Boulevard - Suite 200 Austin, TX 78750. ResultsData were available for 512 patients at 60 months. At 24 months postoperatively, NDI score improvement (area under the curve [AUC]=0.806), absolute NDI score (AUC=0.823), and absolute VAS neck pain score (AUC=0.808) were all excellent predictors of patient satisfaction. At 60 months postoperatively, NDI score improvement (AUC=0.815), absolute NDI score (AUC=0.839), VAS neck pain score improvement (AUC=0.803), and absolute VAS neck pain score (AUC=0.861) were all excellent predictors of patient satisfaction. ConclusionsIn patients undergoing one- and two-level anterior cervical spine surgery, between 2 and 5 years postoperatively, patient satisfaction is significantly predicted by PROs, including the VAS neck score and the NDI.

Letter to the Editor: Mobi-C cervical artificial disc

Letter to the Editor: Mobi-C cervical artificial disc

Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results

The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up. A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the U.S. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery. At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure. Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels. Clinical trial registration no.: NCT00389597 ( clinicaltrials.gov ).

Examining the cost-effectiveness of 2-level cervical total disc replacement.

Cervical total disc replacementwasdeveloped to treat symptomsassociatedwithdiscdegenerationwhilepreservingphysiological motion. Several clinical trials have compared its use with traditional anterior cervical discectomy and fusion for both single-level and multilevel disease.1,2 Ament et al3 analyzed data from a published multicenter randomizedclinical trial by Davis et al4 that demonstrated the clinical superiority of the Mobi-C cervical artificial disc vs anterior discectomy and fusion for 2-level contiguous degenerative disc disease and proposed that 2-level total cervical disc replacement is a cost-effective intervention. This is a potentially significant conclusion. As health care costs continue to increase, there is growing scrutiny ofmedical and surgical treatments offered topatients that, despite efficacy,maybecostprohibitive.Using thequality-adjusted lifeyear scale, the authors showed that 2-level cervical total disc replacement is a cost-effective treatment modality.3 However, several limitationsneed tobeconsidered.First, datawere derived from a multicenter randomized clinical study with strict inclusionandexclusion criteria.As such, the resultsmay not be generalizable to the general populationof patientswho are candidates for anterior cervical surgery. In addition, although thedecisionanalyticmodelingused in thestudyseems reasonable, assumptions that may not be valid were used for the analysis. Even so, the results of this study provide compelling evidence that cervical total disc replacement is a costeffective option for 2-level symptomatic cervical spondylitic disease.

Two-level total disc replacement with Mobi-C(r) over 3-years

Objective: To evaluate the safety and effectiveness of two-level total disc replacement (TDR) using a Mobi-C(r) Cervical Artificial Disc at the 36 month follow-up. Methods: a Prospective, randomized, controlled, multicenter clinical trial of an artificial cervical disc (Mobi-C(r) Cervical Artificial Disc) was conducted under the Investigational Device Exemptions (IDE) and the U.S. Food &amp; Drug Administration (FDA) regulations. A total of 339 patients with degenerative disc disease were enrolled to receive either two-level treatment with TDR, or a two-level anterior cervical discectomy and fusion (ACDF) as control. The 234 TDR patients and 105 ACDF patients were followed up at regular time points for three years after surgery. Results: At 36 months, both groups demonstrated an improvement in clinical outcome measures and a comparable safety profile. NDI scores, SF-12 PCS scores, patient satisfaction, and overall success indicated greater statistically significant improvement from baseline for the TDR group, in comparison to the ACDF group. The TDR patients experienced lower subsequent surgery rates and a lower rate of adjacent segment degeneration. On average, the TDR patients maintained segmental range of motion through 36 months with no device failure. Conclusion: Results at three-years support TDR as a safe, effective and statistically superior alternative to ACDF for the treatment of degenerative disc disease at two contiguous cervical levels.

Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing Mobi-C Cervical Artificial Disc to anterior discectomy and fusion in the treatment of symptomatic degenerative disc disease in the cervical spine.

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

Collective commentaries regarding two articles disputing value of cervical disc arthroplasty vs. Anterior cervical diskectomy and fusion.

Collective commentaries regarding two articles disputing value of cervical disc arthroplasty vs. Anterior cervical diskectomy and fusion.

Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial

Cervical total disc replacement (TDR) is intended to treat neurological symptoms and neck pain associated with degeneration of intervertebral discs in the cervical spine. Anterior cervical discectomy and fusion (ACDF) has been the standard treatment for these indications since the procedure was first developed in the 1950s. While TDR has been shown to be a safe and effective alternative to ACDF for treatment of patients with degenerative disc disease (DDD) at a single level of the cervical spine, few studies have focused on the safety and efficacy of TDR for treatment of 2 levels of the cervical spine. The primary objective of this study was to rigorously compare the Mobi-C cervical artificial disc to ACDF for treatment of cervical DDD at 2 contiguous levels of the cervical spine. This study was a prospective, randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc conducted at 24 centers in the US. The primary clinical outcome was a composite measure of study success at 24 months. The comparative control treatment was ACDF using allograft bone and an anterior plate. A total of 330 patients were enrolled, randomized, and received study surgery. All patients were diagnosed with intractable symptomatic cervical DDD at 2 contiguous levels of the cervical spine between C-3 and C-7. Patients were randomized in a 2:1 ratio (TDR patients to ACDF patients). A total of 225 patients received the Mobi-C TDR device and 105 patients received ACDF. At 24 months only 3.0% of patients were lost to follow-up. On average, patients in both groups showed significant improvements in Neck Disability Index (NDI) score, visual analog scale (VAS) neck pain score, and VAS arm pain score from preoperative baseline to each time point. However, the TDR patients experienced significantly greater improvement than ACDF patients in NDI score at all time points and significantly greater improvement in VAS neck pain score at 6 weeks, and at 3, 6, and 12 months postoperatively. On average, patients in the TDR group also maintained preoperative segmental range of motion at both treated segments immediately postoperatively and throughout the study period of 24 months. The reoperation rate was significantly higher in the ACDF group at 11.4% compared with 3.1% for the TDR group. Furthermore, at 24 months TDR demonstrated statistical superiority over ACDF based on overall study success rates. The results of this study represent the first available Level I clinical evidence in support of cervical arthroplasty at 2 contiguous levels of the cervical spine using the Mobi-C cervical artificial disc. These results continue to support the use of cervical arthroplasty in general, but specifically demonstrate the advantages of 2-level arthroplasty over 2-level ACDF. Clinical trial registration no.: NCT00389597 (ClinicalTrials.gov).