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
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Sponsor:
Stryker Trauma GmbH
Information provided by (Responsible Party):
Stryker Trauma GmbH
Tracking Information | |||||||
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First Submitted Date | February 27, 2019 | ||||||
First Posted Date | February 28, 2019 | ||||||
Last Update Posted Date | October 19, 2020 | ||||||
Actual Study Start Date | June 25, 2019 | ||||||
Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures |
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.
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Change History | |||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | A Post-Market Clinical Evaluation of the ReUnion TSA System | ||||||
Official Title | A Post-Market Clinical Evaluation of the ReUnion TSA System | ||||||
Brief Summary | This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of one hundred (100) 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 TSA System. Efficacy/performance of the procedure will be measured the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion TSA 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. | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Probability Sample | ||||||
Study Population | 100 subjects are to be enrolled in this clinical investigation. 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. | ||||||
Condition | Shoulder Arthroplasty | ||||||
Intervention | 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.
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Study Groups/Cohorts | ReUnion TSA System
Subject with one or more of the following diagnoses will be treated with the ReUnion TSA System:
Intervention: Device: ReUnion TSA System
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Recruiting | ||||||
Estimated Enrollment |
100 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | August 2030 | ||||||
Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 99 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts |
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Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03858517 | ||||||
Other Study ID Numbers | ReUnion TSA Study | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Stryker Trauma GmbH | ||||||
Study Sponsor | Stryker Trauma GmbH | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Stryker Trauma GmbH | ||||||
Verification Date | October 2020 |