Recruiting

Aptis PRUJ

Sponsor:

Aptis Medical

Code:

NCT05796908

Conditions

Arthritis

Unstable Radial Head

Proximal Radioulnar Joint Instability

Decreased Motion at the Proximal Radioulnar Joint and/or the Radio-humeral Joint

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Aptis PRUJ Prosthesis

Study Details

Brief 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

Conditions

Arthritis

Unstable Radial Head

Proximal Radioulnar Joint Instability

Decreased Motion at the Proximal Radioulnar Joint and/or the Radio-humeral Joint

Study ID

NCT05796908

Start date

Apr 12, 2024

Status verified date

Jun, 2026

Completion date

Nov, 2030

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

1. Patient is skeletally mature and under 85 years of age.
2. 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
3. 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:

1. Pain at terminal flexion/extension
2. 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

Study Design

Enrollment

84 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Aptis PRUJ Prothesis

Investigational Aptis PRUJ Prothesis treatment

Interventions

Aptis PRUJ Prosthesis

A prosthetic implant for replacement of the proximal radial ulna joint.

Primary outcome measure

  • Sucess [ Time Frame: 24 months ]

Central Contacts and Locations

Locations

Indiana Hand to Shoulder Center

Recruiting

Carmel, Indiana, United States, 46260

Contacts

Kleinert Kutz Hand Care Center

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Orthopedic Associates of Southwest Ohio

Recruiting

Dayton, Ohio, United States, 45459

Contacts

Lehigh Valley Health Network

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

More Information

Sponsor

Aptis Medical

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • PRUJ
  • Disorders
  • radio-humeral joint
  • proximal radioulnar joint

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Aptis Medical on 2026-06-12.