A Post-Market Clinical Evaluation of the ReUnion TSA System

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Shoulder Arthroplasty

Clinical Trial Details

NCT number	NCT03858517
Study type	Observational
Source	Stryker Trauma GmbH
Contact
Status	Terminated
Phase
Start date	June 25, 2019
Completion date	July 8, 2022

View Details

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