A Post-Market Clinical Evaluation of the ReUnion TSA System
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 3/13/2019 |
| Start Date: | April 2019 |
| End Date: | August 2030 |
| Contact: | Georgia Mitchell, MA |
| Email: | georgia.mitchell@stryker.com |
| Phone: | 609-709-9373 |
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.
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.
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 Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the
ReUnion TSA System will be demonstrated through reporting of device-related intra-operative
and post-operative Adverse Events (AEs). Enrolled subjects will be assessed at Pre-Operative,
Operative/Discharge, and at 6 Weeks, 6 Months, 12 Months, 24 Months and annually thereafter
up to 10 years following the index procedure.
efficacy/performance of the ReUnion TSA System. Efficacy/performance of the procedure will be
measured the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the
ReUnion TSA System will be demonstrated through reporting of device-related intra-operative
and post-operative Adverse Events (AEs). Enrolled subjects will be assessed at Pre-Operative,
Operative/Discharge, and at 6 Weeks, 6 Months, 12 Months, 24 Months and annually thereafter
up to 10 years following the index procedure.
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 pathologic fracture of the proximal humerus.
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