A Post-Market Clinical Evaluation of theReUnion Reverse Shoulder Arthroplasty (RSA)System
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|ClinicalTrials.gov Identifier: NCT03880955|
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment|
|Shoulder Arthroplasty||Device: ReUnion RSA System|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||A Post-Market Clinical Evaluation of theReUnion Reverse Shoulder Arthroplasty (RSA)System|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||August 2030|
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:
Device: ReUnion RSA System
The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA System are to achieve pain relief, improvement of range of motion and restoration or improvement of the shoulder function while ensuring long-term replacement of the shoulder joint with sufficient stability of all endoprosthesis components.
- American Shoulder and Elbow Surgeons (ASES) Shoulder Score [ Time Frame: 24 Months ]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
- Safety will be measured by capturing the incidence rate of device-related intra-operative and post-operative adverse events will be measured. [ Time Frame: 10 years ]Secondary outcome measures to assess safety by capturing the incidence rate of device-related intra-operative and 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. [ Time Frame: 10 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880955
|Contact: Georgia Mitchell, MAemail@example.com|
|United States, South Carolina|
|Steadman Hawkins Clinic of the Carolinas||Not yet recruiting|
|Greenville, South Carolina, United States, 29615|
|Study Director:||Georgia Mitchell, MA||Stryker Trauma|