ClinicalTrials.gov Identifier: NCT03060057
United Orthopedic Corporation is sponsoring a post market study (PAS) to evaluate the clinical performance of the U2 Knee™ System along with the associated surgical instruments, and surgical technique. The device used in this PAS are cleared to market by the Food and Drug Administration (FDA) and will be used in accordance with the cleared labeling and indications for use.
Intended Use of the Study Device
The U2 Knee™ System used in this study is cleared by the U.S. Food and Drug Administration (FDA) for commercial distribution.
The U2 Knee™ System is intended for use in subjects who require primary total knee arthroplasty (TKA) for reduction of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle.
The U2 Knee™ System is provided sterile and intended for single use only.
Duration of the Study
Clinical Trial Locations and Additional Sites
The following locations are the current active clinical study sites for this study:
Coastal Orthopedics & Sports Medicine | Pain Management
Study Coordinator: Carol Collins
904-388-1400 x 5012 or 904-301-3252
Orthopaedic Center of Vero Beach
Vero Beach, FL
Study Coordinator: Nicki Allen