About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
A proximal radio ulnar joint that cannot be reduced intraoperatively
Inadequate bone quality that would allow for implant placement
Trial design
Single group
Treatments tested in this trial
Aptis PRUJ Prosthesis
DeviceA prosthetic implant for replacement of the proximal radial ulna joint.
Treatment groups
Trial outcomes
Primary outcomes
Sucess
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
Secondary outcomes
Effectiveness
The following secondary endpoints will evaluate the effectiveness of the investigational device: * Pre- vs. Post-operative function assessed via Mayo Elbow Performance Score * Mayo Subscores * Pain * Range of motion * Instability * Function
Effectiveness
Changes in overall health at all follow-up time points assessed via SF-36
Effectiveness
Change in disability index assessed at all follow-up time points via DASH
Radiographic
Radiolucencies around radial stem and ulnar screws
Sponsors and contacts
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Aptis Medical
Lead sponsor
MCRA
Collaborator