A Prospective, Multi-Center, Single-Arm Clinical Trial of the Safety and Effectiveness of the Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.
Aptis Medical
Summary
A Prospective, Multi-Center, Single-Arm Clinical Trial of the safety and effectiveness of the Aptis PRUJ prosthesis for the treatment of patients with proximal radial ulna joint disorders
Description
This is a prospective, multi-center, single-arm clinical trial of the safety and effectiveness of the Aptis PRUJ prosthesis for the treatment of patients with proximal radial ulna joint disorders. A total of 84 patients will be enrolled in this trial with 9 centers participating in the US. The total study duration will be approximately 36 months, with an enrollment period of 12 months, followed by a 24 month follow-up period. Annual visits will continue until the last patient reaches the 2-year post-operative time point.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * In order to be eligible to participate in this study, subjects must meet all of the following criteria: 1. Patient is skeletally mature and under 85 years of age. 2. Patient has a painful, unstable radial head due to degeneration or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radioulnar joint and is otherwise 3. Patients willing and able to understand and sign the informed consent. In the opinion of the Investigator, the patient has the understanding and willingness to comply with all study req…
Interventions
- DeviceAptis PRUJ Prosthesis
A prosthetic implant for replacement of the proximal radial ulna joint.
Locations (6)
- Indiana Hand to Shoulder CenterCarmel, Indiana
- Kleinert Kutz Hand Care CenterLouisville, Kentucky
- Massachusetts General HospitalBoston, Massachusetts
- Orthopedic Associates of Southwest OhioDayton, Ohio
- Lehigh Valley Health NetworkAllentown, Pennsylvania
- University of Pennsylvania Perelman School of MedicinePhiladelphia, Pennsylvania