RecruitingNot ApplicableNCT02555280

Coflex PS3 Actual Conditions for Use Study

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.

Sponsor

Xtant Medical

Enrollment

300 participants

Start Date

Sep 9, 2019

Study Type

INTERVENTIONAL

Conditions

Spinal Stenosis Lumbar

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tracks real-world outcomes of the Coflex PS3 interspinous spacer device, which is implanted in the lower spine to treat lumbar stenosis (narrowing of the spinal canal) by relieving pressure on compressed nerves and reducing back and leg pain. You may be eligible if: - You have moderate or severe lumbar spinal stenosis at one or two levels between L1 and L5 - You have back pain (at least 50/100 on a pain scale) and leg pain that improves when you sit down - You have had at least one lumbar injection or at least 6 months of conservative treatment without adequate relief - Your Oswestry disability score is 40% or higher - You are skeletally mature (bones fully grown) You may NOT be eligible if: - You have had prior spinal fusion or decompression surgery at the affected level - You have spinal fractures, tumors, or severe scoliosis - You have severe osteoporosis - You are morbidly obese (BMI over 40) - You have cauda equina syndrome (bowel or bladder dysfunction from nerve compression) - You have an active infection - You have an allergy to titanium or MRI contrast agents Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEcoflex® Interlaminar Technology

Decompression plus coflex® Interlaminar Technology

PROCEDUREDecompression

Decompression alone

Locations(19)

Desert Institute for Spine Care (DISC)

Phoenix, Arizona, United States

Hoag Orthopedics

Irvine, California, 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

Mercy Regional Medical Center

Durango, 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

Orthopaedic Specialist of Northwest Indiana

Munster, Indiana, United States

Spine Institute of Louisiana

Shreveport, Louisiana, United States

St. Joseph's Medical Center

Wayne, New Jersey, United States

Northwell Health Physician Partners Orthopaedic Institute at Great Neck

Great Neck, New York, United States

Consulting Orthopaedic Associates

Toledo, Ohio, 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

View Full Details on ClinicalTrials.gov

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NCT02555280

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