A Study Comparing the Outcome of a Large-Diameter versus Small-Diameter Glenosphere (Shoulder/Arm Ball-Joint) in Primary Reverse Shoulder Arthroplasty
Overview
Tab Title Description
Study type
InterventionalDescribes 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
- Rochester, Minnesota: 15-006839
NCT ID: NCT02768597
Sponsor Protocol Number: 15-006839
About this study
The purpose of this study is to compare the outcome of primary reverse shoulder arthroplasty using the Stryker ReUnion System with the implantation of either a large (40 mm) or a small (36 mm) glenosphere (shoulder to arm, ball shaped joint).
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
- Willing to sign the informed consent
- Male and non-pregnant female subjects ages 50 - 90 at the time of surgery
- Require a primary reverse total shoulder arthroplasty
- Have the diagnosis of cuff-tear arthropathy (CTA), massive irreparable rotator cuff tear (MRCT) or osteoarthritis (OA) with marked posterior subluxation or bone loss
Exclusion Criteria
- Inability to comply with follow-up requirements
- Have inflammatory arthritis
- Have proximal humerus fractures
- Have sequels of trauma
- Are immunologically compromised
- Have an active or suspected latent infection in or about the shoulder
- Need to add a tendon transfer
- Need a structural humeral bone graft
- Are pregnant
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Mark Morrey, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available