Evaluation of coflex® device for treating lumbar spinal stenosis

A 2 and 5 Year Evaluation of Clinical Outcomes in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With Additional Stabilization Using the Coflex® Interlaminar Technology for FDA Actual Conditions for Use Study.

This study is testing if the coflex® device can help people with lumbar spinal stenosis and low back pain feel better after surgery over a period of 2 to 5 years.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xtant Medical (Industry-sponsored)
• Locations: 19 sites (Phoenix, Arizona and 18 other locations)
• Trial ID: NCT02555280 on ClinicalTrials.gov

What this trial studies

This study evaluates the clinical outcomes of using the coflex® Interlaminar Technology for patients with degenerative spinal stenosis and low back pain over a period of 2 to 5 years. It is a prospective, multi-center trial that includes a controlled design to assess both safety and efficacy under actual conditions of use. Participants will undergo decompression surgery with the coflex device, and their outcomes will be monitored through various assessments, including pain scales and disability questionnaires.

Who should consider this trial

Good fit: Ideal candidates include individuals with moderate lumbar stenosis requiring surgical intervention and experiencing significant back pain and neurogenic claudication.

Not a fit: Patients who have not experienced adequate relief from conservative treatments or who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from lumbar spinal stenosis and associated low back pain.

How similar studies have performed: Other studies using similar decompression and stabilization techniques have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 that require surgical decompression.
2. Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale.
3. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair.
4. Subject has undergone at least one lumbar injection at any prior time point, AND/OR at least 6 months of prior conservative care without adequate and sustained symptom relief.
5. Skeletally mature
6. Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%).
7. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
8. Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

1. Prior fusion or decompressive laminectomy at index lumbar level.
2. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture).
3. Severe facet hypertrophy that requires extensive bone removal which would cause instability.
4. Isthmic spondylolisthesis or spondylolysis (pars fracture).
5. Degenerative lumbar scoliosis (Cobb angle of greater than 25°).
6. Osteoporsis or is at increased risk of osteoporosis.
7. Back or leg pain of unknown etiology.
8. Axial back pain only, with no leg, buttock, or groin pain.
9. Morbid obesity defined as a body mass index \> 40.
10. Known allergy to titanium, titanium alloys, or MR contrast agents.
11. Active or chronic infection - systemic or local.
12. Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.

Where this trial is running

Phoenix, Arizona and 18 other locations

• Desert Institute for Spine Care (DISC) — Phoenix, Arizona, United States (Recruiting)
• Hoag Orthopedics — Irvine, California, United States (Withdrawn)
• Sutter Health — Sacramento, California, United States (Recruiting)
• Central Cost Neurological Surgery — San Luis Obispo, California, United States (Recruiting)
• Cervical Disc Center of Los Angeles — Santa Monica, California, United States (Recruiting)
• UC Health Spine Center — Aurora, Colorado, United States (Recruiting)
• Mercy Regional Medical Center — Durango, Colorado, United States (Withdrawn)
• Tallahassee Neurological Clinic — Tallahassee, Florida, United States (Terminated)
• 01L_Northshore University Health System — Evanston, Illinois, United States (Completed)
• 24_Unity Surgical Center, LLC — Lafayette, Indiana, United States (Terminated)
• Orthopaedic Specialist of Northwest Indiana — Munster, Indiana, United States (Withdrawn)
• Spine Institute of Louisiana — Shreveport, Louisiana, United States (Terminated)
• St. Joseph's Medical Center — Wayne, New Jersey, United States (Withdrawn)
• Northwell Health Physician Partners Orthopaedic Institute at Great Neck — Great Neck, New York, United States (Recruiting)
• Consulting Orthopaedic Associates — Toledo, Ohio, United States (Withdrawn)
• Southern Oregon Orthpaedics — Medford, Oregon, United States (Recruiting)
• Summit Spine — Portland, Oregon, United States (Recruiting)
• 03L_Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Terminated)
• Austin Neurosurgeons — Austin, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Laura Henderson

Conditions Spinal Stenosis Lumbar; moderate lumbar stenosis; neurogenic claudication; spinal stenosis; low back pain; decompression