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Aptis PRUJ Prosthesis for Proximal Radial Ulna Joint Disorders

This study is testing the Aptis PRUJ Prosthesis, a device designed to replace your proximal radial ulna joint (the joint near your elbow that allows your forearm to rotate). It's for people aged 18 to 85 who have a painful, unstable radial head (the top part of the forearm bone) due to arthritis or injuries. You might experience pain, a grinding feeling (crepitation), and difficulty moving your arm. The main goal is to see how successful the prosthesis is after 24 months. This is a multi-center study, meaning it's happening at several locations, and aims to include 84 patients.

Study design
This is a single-arm study, meaning all 84 participants will receive the Aptis PRUJ Prosthesis. It is being conducted at 9 centers across the US.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after their surgery, with annual visits continuing until the last patient reaches this 2-year mark.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05796908

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

Recruiting
NAAges 18–85InterventionalTreatment
Aptis Medical
~84 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Aptis PRUJ Prosthesis

At a glance

Recruiting sites
6 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sucess
Measured over 24 months

Conditions

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

Explore related trials

ArthritisProximal Radioulnar Joint InstabilityRadial Head Instability

Where it's being run

7 sites across 6 states
Pennsylvania2
Indiana1
Kentucky1
Massachusetts1
Ohio1
Wisconsin1

Study leadership

  • John Scheker · STUDY_CHAIR · Aptis Medical

Who to contact

Ana Villagomez
[email protected]
5716747734
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

In order to be eligible to participate in this study, subjects must meet all of the following criteria:

Exclusion

1\. Inadequate bone stock or soft tissue coverage 2. Patients with severe humeral/ulnar arthritis, defined as:
A proximal radio ulnar joint that cannot be reduced intraoperatively
Inadequate bone quality that would allow for implant placement
Not enough radius bone proximally for device implantation

What this trial measures

  • Sucess24 months

    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 removals through 24 months