A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System

Study Overview
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Brief Summary
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This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 5-10 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty patients, which entails clinical evaluation on a regular ongoing basis, or as needed should the patient become symptomatic in the treated joint.

Detailed Description
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The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion RFX System. Efficacy/performance of the procedure will be measured by the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion RFX System will be demonstrated through reporting of device-related intraoperative and postoperative Adverse Events (AEs). Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6 Months, 12 Months, 24 Months and annually thereafter up to 10 years following the index procedure.

Official Title
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A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System

Conditions
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Arthroplasty, Hemiarthroplasty, Shoulder Pain

Intervention / Treatment
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* Device: ReUnion Total Shoulder Arthroplasty (TSA)
* Device: ReUnion Reverse Shoulder Arthroplasty (RSA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is willing to sign the informed consent. Subject is willing and able to comply with postoperative scheduled clinical evaluations. Subject is male or non-pregnant female and 18 years or older at the time of surgery. When used with ReUnion Total Shoulder Arthroplasty (TSA)Humeral & Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement, subject has one or more of the following: Aseptic necrosis of humeral head; Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; Proximal humeral fracture and/or dislocation; Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results; Previous unsuccessful total shoulder replacement, resurfacing or other procedure When used with ReUnion RSA Humeral & Glenoid Components as a primary, fracture or revision total shoulder replacement, subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant, and subject has one or more of the following: Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis; Proximal humeral fracture Previously failed shoulder joint replacement Exclusion Criteria: Subject has an active or suspected latent infection in or about the shoulder joint. Subject has mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care. Subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis. Subject has anticipated activities which would impose high stresses on the prosthesis and its fixation. Subject is obese such that he/she produces a load on the prosthesis which can lead to failure of fixation of the device or to failure of the device itself. Subject has severe concomitant disease(s)which may significantly affect the clinical outcome. For Total Shoulder Arthroplasty and Hemiarthroplasty: Subject has absent, irreparable or non-functioning rotator cuff and other essential muscles

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm A Total Shoulder Arthroplasty / Hemiarthroplasty<br>Total Shoulder Arthroplasty (TSA) Humeral & Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement. | Device: ReUnion Total Shoulder Arthroplasty (TSA)<br>* The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.<br>|
| Arm B Reverse Shoulder Arthroplasty<br>Reverse Shoulder Arthroplasty (RSA) Humeral & Glenoid Components as a primary, fracture or revision total shoulder replacement | Device: ReUnion Reverse Shoulder Arthroplasty (RSA)<br>* The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-month mean ASES shoulder score: Arm A (Total Shoulder Arthoplasty/Hemiarthroplasty) | This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. | 24 months | 
| 24-month mean ASES shoulder score: Arm B (Reverse Shoulder Arthroplasty) | This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related adverse events | Incidence of intraoperative and post-operative adverse events related to the device will be collected and reported. Time to earliest device-related incident will be analyzed. | 10 years | 
| Implant survivorship | Time to mortality or last available assessment will be measured and reported. | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder, Arthroplasty, Hemiarthroplasty, Replacement