A Study To Collect Clinical Outcomes Of Anatomic And Reverse Total Shoulder Arthroplasty
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 18-000723
NCT ID: NCT03511586
Sponsor Protocol Number: 18-000723
About this study
The purpose of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
- An advanced pre-operative image (CT or MRI) is obtained prior to surgery.
- Subject has failed 6 months of conservative treatment, unless acute humeral fracture, and will be surgically treated with a primary or revision implantation of an anatomic or reverse shoulder prosthesis system manufactured by Arthrex..
Exclusion Criteria
- Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study.
- The patient has known co-morbidity that would make the subject ineligible for a shoulder arthroplasty procedure.
- Patient declines participating in the study.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator John Tokish, M.D. |
Open for enrollment |
|
More information
Publications
Publications are currently not available