#388 Results from a Multi-center Post-market Registry of the M6®-L Artificial Lumbar Disc

General Session: Lumbar Therapies Motion Preservation

Presented by: K. Ritter-Lang

Author(s):

K. Ritter-Lang (1)
C. Schätz (2)
T. Bierstedt (3)
L. Nel (4)

(1) Semper Mobilitas Orthopädie und Wirbelsäulenchirurgie, Potsdam, Germany
(2) Orthopädische Klinik Markgröningen, Markgröningen, Germany
(3) Orthopädisch-Neurochirurgisches Zentrum, Recklinghausen, Germany
(4) Nel Spinal Surgery, Pretoria, South Africa

Abstract

Purpose: The Spinal Kinetics M6®-L is an advanced generation, one-piece artificial lumbar disc comprised of keeled titanium endplates, a compressible polymer core and a polyethylene woven fiber annulus. The device carries the CE mark and is currently available in Europe and other select countries. First human implants were performed in Germany in February of 2009, where a post-market registry was initiated for the purpose of validating the safety and effectiveness of the M6-L device.

Methods: This is a multi-center, single arm, prospective post-market registry. Consecutive patients presenting for surgery with lumbar degenerative disc disease who agreed to participate were enrolled at each site. Clinical outcome measures include the Oswestry Disability Index (ODI) and back and leg Visual Analogue Scales (VAS). Data is collected pre-operatively, peri-operatively and post-operatively at 6 weeks, 3 months, 6 months and yearly thereafter. AP, lateral and flexion/extension x-rays are performed for radiographic analysis. Patients are monitored continuously by clinical and radiographic criteria to track complications.

Results: One hundred one (101) patients have been enrolled in the registry, including 50 males and 51 females with a mean age of 44 years. Sixty seven (67) patients were treated at 1 level, 31 at 2 levels, and 3 at 3 levels between L3 and S1. Mean ODI has decreased significantly (p< 0.0001) from 45.1 ± 18.3% at baseline to 19.1 at 2 years post-implant. Low back pain has also decreased significantly (p< 0.0001) from baseline with a preoperative mean back pain VAS value of 7.0 and a 2 year value of 2.6. Physiologic disc height and range of motion were attained post-operatively and have been maintained over time. There have been no reported unanticipated or device related serious complications.

Conclusions: Long-term follow-up results from the M6-L artificial lumbar disc post-market registry indicate that the device is safe and effective when used for the treatment of lumbar degenerative disc disease.