A Post-Market Clinical Evaluation of the ReUnion TSA System
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Shoulder Arthroplasty
- Sponsor
- Stryker Trauma and Extremities
- Enrollment
- 51
- Locations
- 3
- Primary Endpoint
- American Shoulder and Elbow Surgeons (ASES) Shoulder Score
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time Frame: 24 months
The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Secondary Outcomes
- Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative and Post-operative Adverse Events Will be Measured.(24 mths)
- Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Total or Partial Prosthesis With Full or Partial Implant Survival.(From Baseline to last recorded follow-up (~27 Months))