Total Shoulder Arthroplasty Multi-Center Registry study
Mark Dillon
Primary Investigator
Brief description of study
What is the purpose of this study?
This study is an ongoing, non-randomized, multi-center, prospective registry utilizing primary or revision shoulder arthroplasty implants. Subjects will be treated according to standard of care at each center. The objective of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.
Detailed description of study
What will happen during the study?
This study will collect real-world clinical outcomes of anatomic and reverse total shoulder arthroplasties. Research procedures will be conducted at IU Health Saxony Orthopedic Clinic and IU Health Musculoskeletal Center at Methodist Medical Plaza North.
Subjective outcomes measures collected are:
• Western Ontario Osteoarthritis of the Shoulder Index
(WOOS)
• Veterans RAND 12 Item Health Survey (VR-12)
• American Shoulder and Elbow Surgeons (ASES) -
subjective score
• Constant Score - PRO
• Single Assessment Numeric Evaluation score (SANE)
• Standard Pre and Post Operative forms
• Return to work
• Visual Analog Scale (VAS)
Objective outcomes measures collected are:
• Constant Score – Clinic
• American Shoulder and Elbow Surgeons (ASES)–
objective
• Range of Motion (ROM)
• Strength
The total enrollment goal is a minimum of 500 anatomic shoulder arthroplasty and 500 reverse shoulder arthroplasty subjects enrolled in the multi-center registry. Enrollment is open ended, with estimated subject participation of ten years.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Shoulder Arthroplasty
-
Age: 18 years - 100 years
-
Gender: All
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
1. Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study.
