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A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System

2019-09-18 03:27:31 | BioPortfolio

Summary

This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 5-10 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty patients, which entails clinical evaluation on a regular ongoing basis, or as needed should the patient become symptomatic in the treated joint.

Description

The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion RFX System. Efficacy/performance of the procedure will be measured by the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion RFX System will be demonstrated through reporting of device-related intraoperative and postoperative 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

Conditions

Arthroplasty

Intervention

ReUnion Total Shoulder Arthroplasty (TSA), ReUnion Reverse Shoulder Arthroplasty (RSA)

Location

Steadman Hawkins
Greenville
South Carolina
United States
29615

Status

Not yet recruiting

Source

Stryker Trauma GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-18T03:27:31-0400

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Medical and Biotech [MESH] Definitions

Replacement of the SHOULDER JOINT.

One of the Indian Ocean Islands, east of Madagascar. Its capital is Saint-Denis. It was discovered in 1507 by the Portuguese and claimed by France in 1638. It was first colonized in 1662 as Isle de Bourbon but renamed Reunion in 1793. In 1946 it was made an overseas department of France. The name commemorates the reunion of the revolutionaries from Marseilles with the National Guard in Paris in 1792. (From Webster's New Geographical Dictionary, 1988, p1011; Room, Brewer's Dictionary of Names, 1992, p454; French Embassy)

Replacement for a SHOULDER JOINT.

Also called the shoulder blade, it is a flat triangular bone, a pair of which form the back part of the shoulder girdle.

Partial or total replacement of a joint.

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