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

2014 ◽  
Vol 13 (2) ◽  
pp. 97-103 ◽  
Author(s):  
Reginald Davis ◽  
Pierce Dalton Nunley ◽  
Kee Kim ◽  
Michael Hisey ◽  
Hyun Bae ◽  
...  
Keyword(s):  
Degenerative Disc Disease ◽  
Total Disc Replacement ◽  
Adjacent Segment Degeneration ◽  
Disc Replacement ◽  
Cervical Disc ◽  
Adjacent Segment ◽  
Artificial Disc ◽  
Disc Disease ◽  
Degenerative Disc ◽  
Surgery Rates

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 & 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.

scholarly journals 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

2015 ◽  
Vol 22 (1) ◽  
pp. 15-25 ◽  
Author(s):  
Reginald J. Davis ◽  
Pierce Dalton Nunley ◽  
Kee D. Kim ◽  
Michael S. Hisey ◽  
Robert J. Jackson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Degenerative Disc Disease ◽  
Total Disc Replacement ◽  
Disc Replacement ◽  
Adjacent Segment ◽  
Artificial Disc ◽  
Disc Disease ◽  
Degenerative Disc

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)

scholarly journals Posterior Transpedicular Dynamic Stabilization versus Total Disc Replacement in the Treatment of Lumbar Painful Degenerative Disc Disease: A Comparison of Clinical Results

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Tunc Oktenoglu ◽  
Ali Fahir Ozer ◽  
Mehdi Sasani ◽  
Yaprak Ataker ◽  
Cengiz Gomleksiz ◽  
...  
Keyword(s):  
Degenerative Disc Disease ◽  
Total Disc Replacement ◽  
Clinical Results ◽  
Dynamic Stabilization ◽  
Disc Replacement ◽  
Disc Prosthesis ◽  
Disc Disease ◽  
Degenerative Disc ◽  
Duration Of Surgery ◽  
The Mean

Study Design. Prospective clinical study.Objective. This study compares the clinical results of anterior lumbar total disc replacement and posterior transpedicular dynamic stabilization in the treatment of degenerative disc disease.Summary and Background Data. Over the last two decades, both techniques have emerged as alternative treatment options to fusion surgery.Methods. This study was conducted between 2004 and 2010 with a total of 50 patients (25 in each group). The mean age of the patients in total disc prosthesis group was 37,32 years. The mean age of the patients in posterior dynamic transpedicular stabilization was 43,08. Clinical (VAS and Oswestry) and radiological evaluations (lumbar lordosis and segmental lordosis angles) of the patients were carried out prior to the operation and 3, 12, and 24 months after the operation. We compared the average duration of surgery, blood loss during the surgery and the length of hospital stay of both groups.Results. Both techniques offered significant improvements in clinical parameters. There was no significant change in radiologic evaluations after the surgery for both techniques.Conclusion. Both dynamic systems provided spine stability. However, the posterior dynamic system had a slight advantage over anterior disc prosthesis because of its convenient application and fewer possible complications.

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