The M6-C Cervical Disk Prosthesis: First Clinical Experience in 33 Patients.

STUDY

DESIGN

Retrospective study.

OBJECTIVE

To determine the short-term clinical succesrate of the M6-C cervical disk prosthesis in primary and secondary surgery.

SUMMARY OF BACKGROUND DATA: Cervical disk arthroplasty (CDA) provides an alternative to anterior cervical decompression and fusion for the treatment of spondylotic radiculopathy or myelopathy. The prevention of adjacent segment disease (ASD), a possible complication of anterior cervical decompression and fusion, is its most cited--although unproven--benefit. Unlike older arthroplasty devices that rely on a ball-and-socket-type design, the M6-C cervical disk prosthesis represents a new generation of unconstrained implants, developed to achieve better restoration of natural segmental biomechanics. This device should therefore optimize clinical performance of CDA and reduce ASD.

MATERIALS AND

METHODS

All patients had preoperative computed tomography or magnetic resonance imaging and postoperative x-rays. Clinical outcome was assessed using the Neck Disability Index, a Visual Analog Scale, and the SF-36 questionnaire. Patients were asked about overall satisfaction and whether they would have the surgery again.

RESULTS

Thirty-three patients were evaluated 17.1 months after surgery, on average. Nine patients had a history of cervical interventions. Results for Neck Disability Index, Visual Analog Scale, and SF-36 were significantly better among patients who had undergone primary surgery. In this group, 87.5% of patients reported a good or excellent result and 91.7% would have the procedure again. In contrast, all 4 device-related complications occurred in the small group of patients who had secondary surgery.

CONCLUSIONS

The M6-C prosthesis appears to be a valuable addition to the CDA armatorium. It generates very good results in patients undergoing primary surgery, although its use in secondary surgery should be avoided. Longer follow-up is needed to determine to what measure this device can prevent ASD.