A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Arthroplasty
- Sponsor
- Stryker Trauma and Extremities
- Enrollment
- 10
- Locations
- 3
- Primary Endpoint
- 24-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)
- Status
- Terminated
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
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.
Investigators
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:
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
Outcomes
Primary Outcomes
24-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)
Time Frame: 24 months
This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. 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.
12-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)
Time Frame: *12 months (reporting 12mth as more data available)
This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. 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
- Device-related Adverse Events(24 mths)
- Implant Survivorship(10 years)