OBJECT 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. METHODS A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the US. 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. RESULTS 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. CONCLUSIONS 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)

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).

The extreme lateral interbody construct provided the largest stand-alone reduction in ROM compared with literature-reported ALIF and TLIF constructs. Supplemental bilateral pedicle screw-based fixation provided the overall greatest reduction in ROM, similar among all interbody approach techniques. Lateral fixation and unilateral pedicle screw fixation provided intermediate reductions in ROM. Clinically, surgeons may evaluate these comparative results to choose fixation options commensurate with the stability requirements of individual patients.

Spinal pseudomeningoceles and cerebrospinal fluid (CSF) fistulas are uncommon extradural collections of CSF that may result from inadvertent tears in the dural–arachnoid layer, traumatic injury, or may be congenital in origin. Most pseudomeningoceles are iatrogenic and occur in the posterior lumbar region following surgery. The true incidence of iatrogenic pseudomeningoceles following laminectomy or discectomy is unknown; however, the authors of several published reports suggest that the incidence of lumbar pseudomeningoceles following laminectomy or discectomy is between 0.07% and 2%. Pseudomeningoceles are often asymptomatic, but patients may present with recurrence of low-back pain, radiculopathy, subcutaneous swelling, or with symptoms of intracranial hypotension. Very rarely, they present with delayed myelopathy. Although magnetic resonance imaging is the neurodiagnostic study of choice, computerized tomography myelography and radionuclide myelographic study may be helpful diagnostic tools in some cases. Analysis of suspect fluid for β2 transferrin may be a useful adjunctive study. Treatment options include close observation for spontaneous resolution, conservative measures such as bed rest and applicaton of an epidural blood patch, lumbar subarachnoid drainage, and definitive surgical repair.

IntroductionThere 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.

The peak IMP generated by the minimally invasive retractor was significantly less than with the open retractor. Postoperatively, less muscle edema was demonstrated after the minimally invasive lumbar spinal fusion, with lower mean T2 and apparent diffusion coefficient measurements supporting the hypothesis that less damage occurs using a minimally invasive approach.

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.

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