a post-market clinical evaluation of the reunion reversible fracture (rfx) system

Conditions: Arthroplasty; Hemiarthroplasty; Shoulder Pain

Summary: this investigation is a prospective, multi-center clinical investigation. it is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 5-10 sites. the clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty patients, which entails clinical evaluation on a regular ongoing basis, or as needed should the patient become symptomatic in the treated joint.

the objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the reunion rfx system. efficacy/performance of the procedure will be measured by the american shoulder and elbow surgeons (ases) shoulder score. safety of the reunion rfx system will be demonstrated through reporting of device-related intraoperative and postoperative 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.

Eligibility criteria:
inclusion criteria: * subject is willing to sign the informed consent. * subject is willing and able to comply with postoperative scheduled clinical evaluations. * subject is male or non-pregnant female and 18 years or older at the time of surgery. * when used with reunion total shoulder arthroplasty (tsa)humeral \& glenoid components as a hemiarthroplasty or total shoulder replacement, subject has one or more of the following: * aseptic necrosis of humeral head; * painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; * proximal humeral fracture and/or dislocation; * clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results; * previous unsuccessful total shoulder replacement, resurfacing or other procedure * when used with reunion rsa humeral \& glenoid components as a primary, fracture or revision total shoulder replacement, 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; * proximal humeral fracture * previously failed shoulder joint replacement 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 severe concomitant disease(s)which may significantly affect the clinical outcome. * for total shoulder arthroplasty and hemiarthroplasty: subject has absent, irreparable or non-functioning rotator cuff and other essential muscles

Keywords: arthroplasty hemiarthroplasty shoulder replacement