Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.
NCT05796908 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2025-11-03
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
Conditions
- Arthritis
- Unstable Radial Head
- Proximal Radioulnar Joint Instability
- Decreased Motion at the Proximal Radioulnar Joint and/or the Radio-humeral Joint
Interventions
- DEVICE
-
Aptis PRUJ Prosthesis
A prosthetic implant for replacement of the proximal radial ulna joint.
Sponsors & Collaborators
-
MCRA
collaborator INDUSTRY -
Aptis Medical
lead INDUSTRY
Principal Investigators
-
John Scheker · Aptis Medical
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-04-12
- Primary Completion
- 2029-11-30
- Completion
- 2030-11-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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