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A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System

NCT03880955 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2025-01-09

Study results available
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Summary

This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) 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.

Conditions

  • Shoulder Arthroplasty

Interventions

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.

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    lead INDUSTRY

Principal Investigators

  • Rebecca Gibson · Stryker Trauma and Extremities

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2023-12-13
Completion
2023-12-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03880955 on ClinicalTrials.gov