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Coflex PS3 Actual Conditions for Use Study
Sponsor: Xtant Medical
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
Conditions
Interventions
coflex® Interlaminar Technology
Decompression plus coflex® Interlaminar Technology
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