Actively Recruiting
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
Led by Aptis Medical · Updated on 2025-11-03
84
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Aptis Medical
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Aptis PRUJ prosthesis, a device designed to treat patients with disorders of the proximal radial ulna joint. This prospective, multi-center, single-arm clinical trial plans to enroll 84 patients with conditions such as arthritis, unstable radial head, and decreased motion in the affected joints. The study is conducted at 9 centers across the US to better understand outcomes for this patient population. Participants will receive the Aptis PRUJ prosthesis as the investigational treatment. The study includes an enrollment period of 12 months followed by a 24-month follow-up period, totaling approximately 36 months. During this time, patients will have annual visits until the last participant reaches 2 years after surgery, allowing for ongoing monitoring of the device's performance and safety. Throughout the trial, participants will undergo evaluations focusing on success at 24 months as the primary outcome. Additional assessments include effectiveness measures, radiographic imaging, and health economic evaluations at multiple time points: 6 weeks, 3 months, 6 months, 12 months, and 24 months. The study also tracks patient adherence to rehabilitation and follow-up visits to ensure comprehensive data collection over the course of the trial.
CONDITIONS
Brief 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 presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radioulnar joint
- Patients willing and able to understand and sign the informed consent
- Patient is willing and 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 with pain at terminal flexion/extension or pain throughout range of motion with loss of motion
- Allergy to implant materials
- Active systemic infection or infection at the surgery site
- Physical interference with or by other prostheses
- Body Mass Index (BMI) greater than 35 kg/m2
- Mental or psychological disorders impairing ability to complete questionnaires
- Significant comorbidities or conditions with high surgical or anesthetic risk
- Medical conditions or circumstances interfering with follow-up visits or rehabilitation
- Conditions precluding adequate evaluation of device safety and performance
- Skin, bone, circulatory, or neurological deficiencies at or affecting the implantation site
- Prisoner status
- Chronic corticosteroid or non-steroidal anti-inflammatory therapy
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Documented history of uncontrolled diabetes
- Known allergies against anesthesia
- History of or current drug or alcohol abuse
- Unlikely to cooperate or legally incompetent
- Legal involvement that hinders completion of two-year follow-up
- Participation in other investigational drug or device studies within past 3 months
- Intra-operative exclusion: inability to reduce proximal radio ulnar joint, inadequate bone quality for implant placement, insufficient proximal radius bone for implantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 12 months
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Day of surgery
Participants receive the Aptis PRUJ prosthetic implant for replacement of the proximal radial ulna joint.
1 surgery visit (in-person)
Duration - 24 months
Participants are monitored with follow-up visits to assess safety and effectiveness of the implant and to support rehabilitation.
Visits at 6 weeks, 3 months, 6 months, 12 months, and 24 months
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
S
Stacy Gardner
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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