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

NCT04089371 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2025-01-20

Study results available
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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.

Conditions

  • Arthroplasty
  • Hemiarthroplasty
  • Shoulder Pain

Interventions

DEVICE

ReUnion Total Shoulder Arthroplasty (TSA)

The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.

DEVICE

ReUnion Reverse Shoulder Arthroplasty (RSA)

The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    lead INDUSTRY

Principal Investigators

  • Rebecca Gibson · Stryker Trauma

Eligibility

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

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2022-07-08
Completion
2022-07-08
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 NCT04089371 on ClinicalTrials.gov