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Survivorship of coflex Interlaminar-Interspinous Implant

Thomas J. Errico, MD,1 Jonathan R. Kamerlink, MD,1 Martin Quirno, MD,1 Jacques Samani, MD,2 Robert J. Chomiak, MS3

1NYU-Hospital for Joint Diseases, New York, New York USA 2Chirurgie Orthopedique, Lyon, France 3Paradigm Spine, LLC, New York, New York USA

Abstract 

Background

The purpose of this study was to determine the indications for implantation of the coflex device (Paradigm Spine, LLC, New York, New York), assess long-term complications, and evaluate the long-term clinical outcomes of patients.

Methods

A total of 127 patients underwent placement of a coflex implant for various indications by one orthopaedic spine surgeon. The mean follow-up was 6.3 years. The original indications for implantation were determined based upon the data provided in the case report forms. Preoperatively and postoperatively, patients were asked to grade their low-back and leg pain using the visual analog scale (VAS) and the pain severity scale: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Patients were queried about their satisfaction with the surgical procedure. Follow-up radiographs were taken to determine any device-related issues.

Results

The most prevalent diagnoses for implantation were spinal stenosis (19.7%) and spinal stenosis with lumbar disc herniation (35.4%). The mean severity of low-back pain was decreased by 33% (from moderate to mild) at the 2-year follow-up (P<.001) and at the 5-year follow-up (from moderate to mild, < .001). The mean severity of leg pain was decreased by 66% (from severe to mild) at the 2-year follow-up (< .001) and at the 5-year follow-up (from severe to mild, < .001). At the mean follow-up period of 6.3 years, a patient satisfaction query demonstrated that 7% were unsatisfied, 46% were satisfied, and 46% were very satisfied with their clinical outcome. Based on the follow-up radiographs, 92 of patients had no device-related issues and 8% had device-related issues.

Conclusion

The data provided have demonstrated that the coflex implant provides pain relief for patients with low-back pain and leg pain. The most common indications for implantation were spinal stenosis and spinal stenosis with lumbar disc herniation. There were very few device-related complications.

Clinical Significance

Using coflex is a safe and viable option in the selection of instrumentation for spinal stabilization.

keywords: 
Interspinous “U”, coflex, interlaminar-interspinous implant, spine arthroplasty, spinal stenosis, long-term outcomes
Volume 3 Issue 2
doi: 
10.1016/S1935-9810(09)70008-8