A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System

Terminated

Brief Summary: This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) subjects will be enrolled at approximately 4-7 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.

Detailed Description: The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion RSA System. Efficacy/performance of the procedure will be measured the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion RSA System will be demonstrated through reporting of device-related intra-operative and post-operative 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.

Recruitment & Eligibility

Inclusion Criteria

Subject is willing to sign the informed consent.
Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
Subject is male or non-pregnant female and 18 years or older at the time of surgery.
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
- Failed previous 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 concomitant disease(s) which may significantly affect the clinical outcome.
Subject has traumatic or pathologic fracture of the proximal humerus

Arm && Interventions

Group	Intervention	Description
ReUnion RSA System	ReUnion RSA System	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 * Failed previous shoulder joint replacement

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) Shoulder Score	24 Months	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. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.

Secondary Outcome Measures

Name	Time	Method
Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative Adverse Events.	24 months	Secondary outcome measures to assess safety by capturing the incidence rate of device-related intra-operative adverse events.
Safety Will be Measured by Capturing the Incidence Rate of Device-related Post-operative Adverse Events.	24 months	Secondary outcome measures to assess safety by capturing the incidence rate of device-related post-operative adverse events.
Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Reverse Total Shoulder Endoprosthesis With the ReUnion RSA System.	24 months	Secondary outcome measures to assess efficacy by monitoring all implant survivorship in all subjects who have the reverse total shoulder endoprosthesis with the ReUnion RSA System.

Locations (3): Great Plains Orthopedics
🇺🇸
Peoria, Illinois, United States
Tennessee Orthopaedic Alliance
🇺🇸
Nashville, Tennessee, United States
Steadman Hawkins Clinic of the Carolinas
🇺🇸
Greenville, South Carolina, United States