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NCT05796908 · ClinicalTrials.gov registry record · NA
Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.
A NA study of Arthritis and Unstable Radial Head, sponsored by Aptis Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 84
- Enrollment target
- 6
- Study locations
NCT05796908: Recruiting NA study of Arthritis and Unstable Radial Head, sponsored by Aptis Medical.
NCT05796908 is a NA study of Arthritis and Unstable Radial Head that is actively recruiting participants, run by Aptis Medical. The registered enrollment target is 84 participants, below the 4,508-participant average among 48 other Arthritis trials with a reported enrollment target (98% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05796908, a NA study of Arthritis and Unstable Radial Head, is actively recruiting participants, sponsored by Aptis Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 84 participants
- Enrollment target
- 6
- Study locations
Study 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
Primary Outcome
A non-inferiority composite primary endpoint for effectiveness and safety, where a subject is considered a success if they meet the following criteria: * Mayo Elbow Performance Score, where success is defined as Good or Excellent at 24 months; and * Absence of radiographic evidence of periprosthetic osteolysis (radiolucent line \>2mm around entire radial stem and ulnar screws), and no screw breakage at 24 months; and * Absence of device-related serious adverse events including any revisions and
Conditions Studied
Interventions
- DEVICE Aptis PRUJ Prosthesis
Study Locations (6)
Pennsylvania
- Lehigh Valley Health Network - Allentown
- University of Pennsylvania Perelman School of Medicine - Philadelphia
Indiana
- Indiana Hand to Shoulder Center - Carmel
Kentucky
- Kleinert Kutz Hand Care Center - Louisville
Massachusetts
- Massachusetts General Hospital - Boston
Ohio
- Orthopedic Associates of Southwest Ohio - Dayton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2024-04-12 |
| Est. Completion | 2030-11 |
| Phase | NA |
What NCT05796908 shows while recruiting
NCT05796908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 4,508-participant average among 48 other Arthritis trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Arthritis appearing as the primary indexed condition, and to 1 intervention - of which Aptis PRUJ Prosthesis is the first listed.
NCT05796908 lists 6 locations in 5 states (Pennsylvania, Indiana, Kentucky).
Frequently Asked Questions
What is clinical trial NCT05796908 about?
NCT05796908 is a clinical study titled "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
What is the current status of trial NCT05796908?
This trial is currently recruiting. It is a NA study. The enrollment target is 84 participants. The study started on 2024-04-12. Estimated completion is 2030-11.
What conditions does trial NCT05796908 study?
This clinical trial studies the following conditions: Arthritis, Unstable Radial Head, Proximal Radioulnar Joint Instability, Decreased Motion at the Proximal Radioulnar Joint and/or the Radio-humeral Joint.
What interventions are being tested in trial NCT05796908?
The interventions under investigation include: Aptis PRUJ Prosthesis (DEVICE).
Who is sponsoring clinical trial NCT05796908?
This trial is sponsored by Aptis Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05796908 being conducted?
This trial has 6 study locations across Indiana, Kentucky, Massachusetts, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05796908's enrollment target sits among peer trials
84 30th of 48 higher than 19 of 48 other Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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