A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System

A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System

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.

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