Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.

Study Overview
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Brief Summary
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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

Detailed Description
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This is 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. A total of 84 patients will be enrolled in this trial with 9 centers participating in the US. The total study duration will be approximately 36 months, with an enrollment period of 12 months, followed by a 24 month follow-up period. Annual visits will continue until the last patient reaches the 2-year post-operative time point.

Official Title
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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
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Arthritis, Unstable Radial Head, Proximal Radioulnar Joint Instability, Decreased Motion at the Proximal Radioulnar Joint and/or the Radio-humeral Joint

Intervention / Treatment
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* Device: Aptis PRUJ Prosthesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aptis PRUJ Prothesis<br>Investigational Aptis PRUJ Prothesis treatment | Device: Aptis PRUJ Prosthesis<br>* A prosthetic implant for replacement of the proximal radial ulna joint.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 weeks, 3 months, 6 months, 12 months, 24 months | 
| Effectiveness | Changes in overall health at all follow-up time points assessed via SF-36 | 6 weeks, 3 months, 6 months, 12 months, 24 months | 
| Effectiveness | Change in disability index assessed at all follow-up time points via DASH | 6 weeks, 3 months, 6 months, 12 months, 24 months | 
| Radiographic | Radiolucencies around radial stem and ulnar screws | 6 weeks, 3 months, 6 months, 12 months, 24 months | 
| Radiographic | Subsidence of radial component | 6 weeks, 3 months, 6 months, 12 months, 24 months | 
| Radiographic | Screw breakage | 6 weeks, 3 months, 6 months, 12 months, 24 months | 
| Radiographic | Ulnar variance | 6 weeks, 3 months, 6 months, 12 months, 24 months | 
| Health Economic | Use of other concomitant medications | 6 weeks, 3 months, 6 months, 12 months, 24 months | 
| Health Economic | Post-operative recovery time (return to daily activities/work) | 6 weeks, 3 months, 6 months, 12 months, 24 months | 
| Health Economic | Post-operative rehabilitation details | 6 weeks, 3 months, 6 months, 12 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRUJ, Disorders, radio-humeral joint, proximal radioulnar joint