NCT05796908 · Aptis Medical
Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.
What this study is about
A forward-looking, Multi-Center, Single-treatment group$1 Clinical Trial of the safety and effectiveness of the Aptis PRUJ prosthesis for the treatment of patients with proximal radial ulna joint disorders
View original scientific description
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- In order to be eligible to participate in this study, subjects must meet all of the following criteria:
- 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 and is otherwise
- Patients willing and able to understand and sign the informed consent. In the opinion of the Investigator, the patient has the understanding and willingness to comply with all study requirements including the post-operative rehabilitation and follow-up visits per protocol.
Exclusion criteria
- 1\. Inadequate bone stock or soft tissue coverage 2. Patients with severe humeral/ulnar arthritis, defined as:
- Pain at terminal flexion/extension
- Pain throughout ROM with loss of motion in terminal flexion and/or extension 3. Patients with an allergy to the implant materials 4. Active systemic infection or infection at the site of surgery 5. Physical interference with or by other prostheses during implantation or use 6. Have a Body Mass Index (BMI) greater than 35 kg/m2 7. Have any mental or psychological disorder that would impair the ability to complete the study questionnaires 8. Have significant comorbidities or conditions associated with high-risk for surgical or anesthetic survival (e.g., renal failure, peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.) 9. Have any medical condition or other circumstances that might interfere with the ability to return for follow-up visits in the judgment of the Investigator, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative rehabilitation 10. Have any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the device's safety and performance 11. Skin, bone, circulatory and/or neurological deficiency at or affecting the implantation site 12. Prisoners 13. Patients on chronic corticosteroid or non-steroidal anti-inflammatory therapy 14. Women who are pregnant or breast-feeding or are planning to become pregnant during the study. 15\. Patients with a documented history of uncontrolled diabetes. 16. Patients with known allergies against anesthesia. 17. Patients with a history of or current drug and/or alcohol abuse 18. Patients unlikely to cooperate or are legally incompetent. 19. Patients with legal involvement, including an active claim for workman's compensation, or any other issue that would hinder completion of the two-year follow period. 20\. Patients who are participating or have participated in any other study involving an investigational drug or device within the past 3 months. Intra-operative Exclusion Criteria Subjects who meet any of the following intra-operative screening criteria will be excluded from participation in this study:
- 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
Where
- Carmel, Indiana
- Louisville, Kentucky
- Boston, Massachusetts
- Dayton, Ohio
- Allentown, Pennsylvania
- Philadelphia, Pennsylvania
- Milwaukee, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations