Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.
Part of paid clinical trials in Carmel, Indiana.
- Sponsor
- Aptis Medical
- Study ID
- NCT05796908
- Status
- Recruiting
Conditions
- Arthritis
- Decreased Motion at the Proximal Radioulnar Joint and/or the Radio-humeral Joint
- Proximal Radioulnar Joint Instability
- Unstable Radial Head
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Accepted
Interventions
- Aptis PRUJ Prosthesis — DEVICEA prosthetic implant for replacement of the proximal radial ulna joint.
Study Details
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
Key Dates
- Start date
- Apr 12, 2024
- Status verified
- Jun 2026
- Primary completion
- Nov 30, 2029
- Completion
- Nov 30, 2030
Study Design
- Enrollment
- 84 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Aptis PRUJ ProthesisInvestigational Aptis PRUJ Prothesis treatment
Primary Outcome Measure
Sucess [ Time Frame: 24 months ]
Central Contacts
- Ana Villagomez5716747734
- Stacy Gardner+44 7345 02 3334
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Indiana Hand to Shoulder Center | Carmel | Indiana | 46260 | |
| Kleinert Kutz Hand Care Center | Louisville | Kentucky | 40202 | |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | |
| Orthopedic Associates of Southwest Ohio | Dayton | Ohio | 45459 | |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | |
| University of Pennsylvania Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | - |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 |
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