NCT03858517

A Post-Market Clinical Evaluation of the ReUnion TSA System

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Shoulder Arthroplasty

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-25
• Primary completion: 2022-07-08
• Completion: 2022-07-08
• First posted: 2019-02-28
• Last updated: 2025-01-31
• Results posted: 2025-01-31

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study