NCT05796908

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

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Aptis Medical · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Arthritis
• Unstable Radial Head
• Proximal Radioulnar Joint Instability
• Decreased Motion at the Proximal Radioulnar Joint and/or the Radio-humeral Joint

Interventions

Type	Name	Description
DEVICE	Aptis PRUJ Prosthesis	A prosthetic implant for replacement of the proximal radial ulna joint.

Timeline

• Start date: 2024-04-12
• Primary completion: 2029-11-01
• Completion: 2030-11-01
• First posted: 2023-04-04
• Last updated: 2025-11-03

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study