A NEW CERVICAL DISC PROSTHESIS: PRELIMINARY RESULTS FROM A MULTICENTRIC PROSPECTIVE STUDY

Abstract

Purpose of the study: Discectomy-anterior fusion has proven efficacy for many diseases of the cervical spine. Nevertheless, the loss of motion and the over-solicitation of adjacent levels are arguments in favor of disc replacement. This prospective study examined the early clinical and radiological results obtained in the first 41 patients treated with a new cervical disc prosthesis, Mobi-C.

Material and methods: A prospective multicentric clinical and radiological study is being conducted to analyze the safety and efficacy of Mobi-C for degenerative disease. Indications are radiculopathies due to discal herniation or foraminal osteophytic stenosis involving one or two levels from C3 to T1. An independent observer reviewed the patients. SF36, the Neck Disability Index, and a visual analogue scale for pain as well as radiographic mobility were noted.

Results: Mean age was 42 years (range 31–56 years). There were 23 men and 18 women. Eight patients had two disc replacements. Mean follow-up was six months (range 3–10 months). Mean operative time was 65 min, similar to operative time for fusion. Blood loss was 90 ml. NSAID were prescribed for the first 15 days. There were no intraopeartive complications and no revisions. Postoperative complications were minimal. There were no specific complications related to the prosthesis, its insertion or its function. The function and quality-of-life scores showed a significant improvement at last follow-up. Radiographically, motion was also improved in most patients.

Discussion: The early results on the safety and efficacy of this new cervical prosthesis are promising. Primary stability has been excellent and there have been no specific prosthesis-related complications. Furthermore, several operators have mentioned how easy it is to insert the Mobi-C.

Conclusion: The clinical results in terms of pain and function as well as the radiological results have been satisfactory both at the early and at the later assessments. Insertion of this prosthesis is a simple process, similar to insertion of an intersomatic cage, elements arguing in favor of a cervical disc prosthesis. Further follow-up will be needed to assess the long-term efficacy and possible effect on prevention of accelerated degeneration of the adjacent discs.