A Post-Market Clinical Evaluation of the ReUnion TSA System

A Post-Market Clinical Evaluation of the ReUnion TSA System

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.

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.

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.