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 clinical trial is studying a procedure called Decompression and a medical device called coflex® Interlaminar Technology for people with spinal stenosis lumbar. The study is currently recruiting participants at 19 locations. People eligible for this study include aged 18 Years and older.

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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