Coflex PS3 Actual Conditions for Use Study

Completed · Not applicable

Conditions studied: Spinal Stenosis Lumbar

In brief

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 of Use Study.

Key facts

Study ID

NCT02555280

Run by

Companion Spine, LLC

People needed

40

Starts

2019-09-09

Expected to finish

2026-05-31

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 that require surgical decompression.
• Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale.
• Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair.
• 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.
• Skeletally mature
• Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%).
• Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
• 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.

You may not qualify if…

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

Where it is running

• Desert Institute for Spine Care (DISC) — Phoenix, Arizona, United States
• Sutter Health — Sacramento, California, United States
• Central Cost Neurological Surgery — San Luis Obispo, California, United States
• Cervical Disc Center of Los Angeles — Santa Monica, California, United States
• UC Health Spine Center — Aurora, Colorado, United States
• Tallahassee Neurological Clinic — Tallahassee, Florida, United States
• 01L_Northshore University Health System — Evanston, Illinois, United States
• 24_Unity Surgical Center, LLC — Lafayette, Indiana, United States
• Spine Institute of Louisiana — Shreveport, Louisiana, United States
• Northwell Health Physician Partners Orthopaedic Institute at Great Neck — Great Neck, New York, United States
• Southern Oregon Orthpaedics — Medford, Oregon, United States
• Summit Spine — Portland, Oregon, United States
• 03L_Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Austin Neurosurgeons — Austin, Texas, United States

Full record on ClinicalTrials.gov

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