A Post-Market Clinical Evaluation of the ReUnion TSA System

Stopped early

Conditions studied: Shoulder Arthroplasty

In brief

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 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.

Key facts

Study ID

NCT03858517

Run by

Stryker Trauma and Extremities

People needed

51

Starts

2019-06-25

Expected to finish

2022-07-08

Last updated by the study team

2025-01-31

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Great Plains Orthopedics — Peoria, Illinois, United States
• Tennessee Orthopaedic Alliance — Nashville, Michigan, United States
• Steadman Hawkins Clinic of the Carolinas — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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