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RECRUITING
NCT02555280
NA

Coflex PS3 Actual Conditions for Use Study

Sponsor: Xtant Medical

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2019-09-09

Completion Date

2027-11

Last Updated

2024-01-05

Healthy Volunteers

No

Interventions

DEVICE

coflex® Interlaminar Technology

Decompression plus coflex® Interlaminar Technology

PROCEDURE

Decompression

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