IDE Clinical Trial Comparing coflex® vs. Fusion to Treat Lumbar Spinal Stenosis (coflex)
Who May Be a Candidate
Men and women age 40- to 80-years, diagnosed with lumbar (low back) spinal stenosis, who have undergone at least 6 months of nonsurgical treatment, including at least 1 epidural steroid injection. Patients may have back pain that affects the buttocks, upper outer thighs, and/or pain extending into the feet. Some patients report pain relief when changing positions.
Product Being Studied
The coflex® device is “investigational,” meaning it is currently being studied in a clinical research trial under the Food and Drug Administration’s (FDA) guidelines. The device is surgically implanted between the spinous processes (the part of the spine that can often be felt through the skin along the center of the back) after spinal decompression.
The device can increase the space through which nerve roots pass between the vertebrae. This increased space helps to reduce symptoms associated with lumbar spinal stenosis such as pain, weakness, and abnormal sensations.
Clinical Trial Sponsor
This clinical trial is sponsored by Paradigm Spine, the company responsible for developing the coflex® interspinous implant technology. The coflex® investigational device is designed to treat lumbar spinal stenosis.
Purpose and Objective
The purpose of the coflex® clinical trial is to evaluate the safety and effectiveness of the device compared to pedicle screw fixation and fusion after decompression. Total enrollment for this study is 460 patients.
This randomized clinical trial involves one of two treatments:
- Experimental stabilization with coflex®
- The procedure is a pedicle screw fixation and posterolateral fusion with autograft bone after decompressive laminectomy
The objective is to evaluate the safety and effectiveness of the coflex device compared to a surgical control; posterolateral fusion with autograft bone and pedicle screw fixation, following decompressive laminectomy for the treatment of 1 or 2 level lumbar stenosis from L1-L5 that requires surgical decompression, and in patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 1 epidural steroid injection and at least 6 months of conservative treatment.
Recruiting Locations (United States)
Arizona
Phoenix
California
Beverly Hills
Colton
Irvine
La Jolla
Rancho Mirage
San Diego
Santa Monica
Colorado
Fort Collins
Loveland
Florida
Sarasota
Tampa
Maryland
Baltimore
MIchigan
Detroit
Royal Oak
Nevada
Las Vegas
New York
New York
Oregon
Bend
Texas
Austin
Dallas
San Antonio
Sherman
Tyler
Eligibility, Inclusion and Exclusion Criteria
Men and women ages 40- to 80-years who meet the following criteria are eligible to participate in this clinical trial.
ClinicalTrials.gov Identifier: NCT00534235
Study ID Numbers: PS-001
Study Type: Interventional
Study Design: Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Prospective, Randomized, Clinical Trial Comparing Stabilization with coflex vs. Pedicle Screw Fixation and Fusion after Decompression for at Least Moderate Lumbar Spinal Stenosis
