A Post-Market Clinical Evaluation of the ReUnion TSA System
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|ClinicalTrials.gov Identifier: NCT03858517|
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment|
|Shoulder Arthroplasty||Device: ReUnion TSA System|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||A Post-Market Clinical Evaluation of the ReUnion TSA System|
|Actual Study Start Date :||June 25, 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||August 2030|
ReUnion TSA System
Subject with one or more of the following diagnoses will be treated with the ReUnion TSA System:
Device: ReUnion TSA System
The ReUnion TSA System is designed as an anatomical total shoulder or hemi-shoulder endoprosthesis to address advanced arthritic disorders affecting the shoulder joint in subjects having intact or repairable rotator cuff function. The ReUnion TSA System consists of a completely modular shoulder platform including a Humeral Stem, Humeral Head and Glenoid. The intended purposes of the ReUnion TSA 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 adverse events.
- Efficacy will be measured by monitoring all implant survivorship in all subjects who have the total or partial prosthesis with full or partial implant survival. [ Time Frame: 10 years ]Secondary outcome measures to assess efficacy by monitoring all implant survivorship in all subjects enrolled who have the ReUnion RFX 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): NCT03858517
|Contact: Colleen Bordeauxemail@example.com|
|United States, Illinois|
|Great Plains Orthopedics||Recruiting|
|Peoria, Illinois, United States, 61605|
|Contact: Eleni Stroumpi, MD 309-655-6988 firstname.lastname@example.org|
|Principal Investigator: Miguel Ramirez|
|United States, Michigan|
|Tennessee Orthopaedic Alliance||Recruiting|
|Nashville, Michigan, United States, 37209|
|Contact: Rena Clayton Rolfe 615-719-2922 email@example.com|
|Principal Investigator: Matthew Willis|
|United States, South Carolina|
|Steadman Hawkins Clinic of the Carolinas||Recruiting|
|Greenville, South Carolina, United States, 29615|
|Contact: Kyle Adams 864-454-7458 firstname.lastname@example.org|
|Principal Investigator: Stefan Tolan|
|Principal Investigator: Stephan Pill|
|Study Director:||Rebecca Gibson||Stryker Trauma|