Status:
TERMINATED
A Post-Market Clinical Evaluation of the ReUnion TSA System
Lead Sponsor:
Stryker Trauma and Extremities
Conditions:
Shoulder Arthroplasty
Eligibility:
All Genders
18-99 years
Brief 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 investig...
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 Should...
Eligibility Criteria
Inclusion
- Subject is willing to sign the informed consent.
- Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
- Subject is male or non-pregnant female and 18 years or older at the time of surgery.
- Subject has one or more of the following:
- Aseptic necrosis of the humeral head
- Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
- Failed previous total shoulder replacement, resurfacing or other procedure
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 absent, irreparable or non-functioning rotator cuff and other essential muscles.
- Subject has concomitant disease(s) which may significantly affect the clinical outcome.
- Subject has traumatic or pathologic fracture of the proximal humerus.
Key Trial Info
Start Date :
June 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 8 2022
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03858517
Start Date
June 25 2019
End Date
July 8 2022
Last Update
January 31 2025
Active Locations (3)
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1
Great Plains Orthopedics
Peoria, Illinois, United States, 61605
2
Tennessee Orthopaedic Alliance
Nashville, Michigan, United States, 37209
3
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, United States, 29615