A Post-Market Clinical Evaluation of the ReUnion TSA System (NCT03858517) | Clinical Trial Compass
TerminatedNot Applicable
A Post-Market Clinical Evaluation of the ReUnion TSA System
Stopped: Sponsor Terminated
United States51 participantsStarted 2019-06-25
Plain-language 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 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 patholo…
What they're measuring
1
American Shoulder and Elbow Surgeons (ASES) Shoulder Score