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Shoulder Arthroplasty

A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System

Sponsored by Stryker Trauma GmbH

About this trial

Last updated 2 years ago

Study ID

ReUnion RSA Study

Status

Active, not recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18 to 80 Years
All
All

Trial Timing

Ended 2 years ago

What is this trial about?

This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) 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.

What are the participation requirements?

Yes

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'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
- Failed previous shoulder joint replacement
No

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 concomitant disease(s) which may significantly affect the clinical outcome.

- Subject has traumatic or pathologic fracture of the proximal humerus