Total Shoulder Arthroplasty Multi-Center Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Shoulder Arthroplasty
- Sponsor
- Arthrex, Inc.
- Enrollment
- 2500
- Locations
- 17
- Primary Endpoint
- Change in Pain
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
The objective of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.
Detailed Description
The study is a non-randomized multi-center prospective registry and subjects will be treated according to standard of care at each center. Subjects will be approached for participation in this study after they have made the decision to undergo a primary or revision shoulder arthroplasty procedure. The treating surgeon will obtain verbal consent from the patient for a research coordinator to screen for eligibility. Patients who meet all criteria will be offered enrollment into the study. The total enrollment goal is a minimum of 500 anatomic shoulder arthroplasty and 500 reverse shoulder arthroplasty subjects enrolled in the multi-center registry.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
- •Patient is between the ages of 18 and 100 years.
- •The patient has a planned primary or revision implantation of an anatomic (hemi-arthroplasty or total arthroplasty) or a reverse shoulder prosthesis system manufactured by Arthrex.
- •Patient has a standard of care preoperative CT taken within 6 months that has been submitted for Arthrex VIP (Virtual Implant Positioning) planning.
- •Exclusion Criteria
- •Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Pain
Time Frame: 10 years
Measure of pain intensity. This is done with the Visual Analog Scare. (VAS)