Spinal implant aims to stabilize the back and ease pain

NCT ID NCT02555280

Completed Disease control Sponsor: Companion Spine, LLC Source: ClinicalTrials.gov ↗

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This trial studies a device called coflex, a small implant placed in the spine after decompression surgery for lumbar spinal stenosis (a narrowing of the spinal canal that causes back and leg pain). The study includes 40 adults with moderate to severe stenosis and low back pain. Half receive decompression plus the coflex implant, and half receive decompression alone. Researchers track pain, disability, and complications over 2 to 5 years to see if the implant improves outcomes.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: coflex® Interlaminar Technology (a spinal implant)
What this could lead to: If successful, this implant could offer a more stable, lasting solution for people with spinal stenosis and low back pain, potentially reducing the need for repeat surgeries.
What could go wrong: This is a small, early-stage study with only 40 participants, so results may not apply to everyone. The implant also carries risks like infection, device failure, or nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Low Back Pain lumbar spinal stenosis spinal stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SPINAL STENOSIS LUMBAR

Contacts and locations

Locations

01L_Northshore University Health System

Evanston, Illinois, 60201, United States
03L_Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States
24_Unity Surgical Center, LLC

Lafayette, Indiana, 47905, United States
Austin Neurosurgeons

Austin, Texas, 78746, United States
Central Cost Neurological Surgery

San Luis Obispo, California, 93401, United States
Cervical Disc Center of Los Angeles

Santa Monica, California, 90404, United States
Desert Institute for Spine Care (DISC)

Phoenix, Arizona, 85020, United States
Northwell Health Physician Partners Orthopaedic Institute at Great Neck

Great Neck, New York, 11021, United States
Southern Oregon Orthpaedics

Medford, Oregon, 97504, United States
Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States
Summit Spine

Portland, Oregon, 97225, United States
Sutter Health

Sacramento, California, 95816, United States
Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States
UC Health Spine Center

Aurora, Colorado, 80045, United States

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