Status:
TERMINATED
A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System
Lead Sponsor:
Stryker Trauma and Extremities
Conditions:
Arthroplasty
Hemiarthroplasty
Eligibility:
All Genders
18-99 years
Brief 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 invest...
Detailed 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 Sho...
Eligibility Criteria
Inclusion
- Subject is willing to sign the informed consent.
- Subject is willing and able to comply with postoperative scheduled clinical evaluations.
- Subject is male or non-pregnant female and 18 years or older at the time of surgery.
- When used with ReUnion Total Shoulder Arthroplasty (TSA)Humeral \& Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement, subject has one or more of the following:
- Aseptic necrosis of humeral head;
- Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;
- Proximal humeral fracture and/or dislocation;
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results;
- Previous unsuccessful total shoulder replacement, resurfacing or other procedure
- When used with ReUnion RSA Humeral \& Glenoid Components as a primary, fracture or revision total shoulder replacement, subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant, and subject has one or more of the following:
- Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis;
- Proximal humeral fracture
- Previously failed shoulder joint replacement
Exclusion
- Subject has an active or suspected latent infection in or about the shoulder joint.
- Subject has mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.
- Subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
- Subject has anticipated activities which would impose high stresses on the prosthesis and its fixation.
- Subject is obese such that he/she produces a load on the prosthesis which can lead to failure of fixation of the device or to failure of the device itself.
- Subject has severe concomitant disease(s)which may significantly affect the clinical outcome.
- For Total Shoulder Arthroplasty and Hemiarthroplasty: Subject has absent, irreparable or non-functioning rotator cuff and other essential muscles
Key Trial Info
Start Date :
October 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 8 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04089371
Start Date
October 1 2019
End Date
July 8 2022
Last Update
January 20 2025
Active Locations (3)
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1
Great Plains Orthopaedics
Peoria, Illinois, United States, 61605
2
Steadman Hawkins
Greenville, South Carolina, United States, 29615
3
Tennessee Orthopaedic Alliance
Nashville, Tennessee, United States, 37209