Abstract
Introduction
To evaluate the clinical efficacy and safety of posterior Coflex dynamic stabilization for the treatment of degenerative lumbar stenosis, a perspective clinical and radiographic study was conducted and 3 to 5 years outcome was reported.
Materials and Methods
Between September 2007 and August 2009, 48 consecutive patients with degenerative lumbar stenosis were prospectively enrolled and treated with selective decompression and Coflex interlaminar dynamic stabilization. There were 23 male and 25 female (age 60.3 years; range, 48-79). Forty-six patients underwent single-level procedure and two patients with two-level procedures. The outcome evaluations were using VAS scale, modified ODI score, and radiographic results with the ROM of surgery and adjacent level as well as complications. All data were analyzed and patient's satisfaction was evaluated at final follow-up examination.
Results
Follow-up examinations were conducted at 1, 3, 6, 12, 24, and 36 months postoperatively and clinical and radiographic evaluations were performed. All patients were followed up at least 36 months (36-60 months, average 45.2 months). The average VAS scale was 8.1 pre-op, 2.9 post-op, and 2.5 at latest follow-up. The ODI score was 54.3 pre-op, 21.8 post-op, and 24.5 at the latest follow-up. All data mentioned above were statistically significantly improved. During follow-up, the range of motions (ROM) of operated levels were maintained (2-6 degrees, average 3.6 degrees) and there was no significant increase of ROM in adjacent level. Seven cases of Coflex device-related complications (14.6%) were occurred, but no patient underwent revision surgery for it.
Conclusion
From this prospective study from single institute, mid- to long-term satisfactory clinical outcome could be achieved in patients with single level of DLS treated by selective decompression and posterior Coflex interlaminar dynamic stabilization, with few device-related complications and ASD occurred.
None declared