Evaluation of the Aptis PRUJ Prosthesis for Treating Proximal Radial Ulna Joint Disorders in a Multi-Center Single-Arm Clinical Trial

What this Trial Is About

Researchers are evaluating the Aptis PRUJ prosthesis in patients with disorders of the proximal radial ulna joint, including arthritis, instability, and decreased motion. This prospective, multi-center, single-arm clinical trial aims to assess the safety and effectiveness of this prosthetic implant as a treatment option. The study will enroll 84 patients across nine centers in the US, with a total duration of about 36 months including enrollment and follow-up. Participants will receive the investigational Aptis PRUJ prosthesis, which replaces the proximal radial ulna joint. The study includes a 12-month enrollment period followed by a 24-month follow-up. After surgery, participants will have annual visits until the last patient reaches two years post-operation. This structure allows researchers to monitor the implants performance and patient outcomes over time. During the study, participants will undergo multiple assessments including effectiveness evaluations and radiographic imaging at 6 weeks, 3 months, 6 months, 12 months, and 24 months post-implantation. Health economic outcomes will also be measured at these intervals. The primary outcome is success at 24 months. Safety and follow-up visits will continue annually to monitor long-term results. Participants can expect regular visits and evaluations throughout the study period.

Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.