Actively Recruiting
Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.
Led by Aptis Medical · Updated on 2025-11-03
84
Participants Needed
6
Research Sites
342 weeks
Total Duration
On this page
Sponsors
A
Aptis Medical
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is skeletally mature and under 85 years of age.
- Patient has a painful, unstable radial head due to degeneration or post-traumatic disabilities causing pain, crepitation, and decreased motion at the radiohumeral and/or proximal radioulnar joint.
- Patients willing and able to understand and sign informed consent.
- Patients able to comply with all study requirements including post-operative rehabilitation and follow-up visits.
You will not qualify if you...
- Inadequate bone stock or soft tissue coverage.
- Severe humeral or ulnar arthritis causing pain at terminal flexion/extension or pain with loss of motion.
- Allergy to implant materials.
- Active systemic or surgical site infection.
- Physical interference with or by other prostheses during implantation or use.
- Body Mass Index greater than 35 kg/m2.
- Mental or psychological disorders impairing ability to complete study questionnaires.
- Significant comorbidities with high surgical or anesthetic risk.
- Medical conditions or circumstances interfering with follow-up or rehabilitation.
- Conditions precluding adequate device safety or performance evaluation.
- Skin, bone, circulatory or neurological deficiencies at or affecting implantation site.
- Prisoner status.
- Chronic corticosteroid or non-steroidal anti-inflammatory therapy.
- Pregnancy, breastfeeding, or planning pregnancy during study.
- Uncontrolled diabetes.
- Known allergies to anesthesia.
- History of or current drug or alcohol abuse.
- Unlikely to cooperate or legally incompetent.
- Legal involvement hindering completion of follow-up.
- Participation in another investigational study within past 3 months.
- Intra-operative exclusion: irreducible proximal radio ulnar joint, inadequate bone quality, insufficient proximal radius bone for device implantation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Indiana Hand to Shoulder Center
Carmel, Indiana, United States, 46260
Actively Recruiting
2
Kleinert Kutz Hand Care Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Orthopedic Associates of Southwest Ohio
Dayton, Ohio, United States, 45459
Actively Recruiting
5
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
6
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
G
Grace Montes
CONTACT
S
Stacy Gardner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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