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

Arthritis Clinical Trial

Official title:
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.

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05796908
Study type Interventional
Source Aptis Medical
Contact Jennifer N Jennings
Phone 12027423861
Email JJennings@mcra.com
Status Not yet recruiting
Phase N/A
Start date June 2023
Completion date November 2026
View Details
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