A Study to Compare the Outcome of Primary Anatomic Shoulder Arthroplasty Using the Stryker ReUnion System with Implantation of Either a Peg or Keel Glenoid Construction.
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: 17-011251
NCT ID: NCT03735173
Sponsor Protocol Number: 17-011251
About this study
The purpose of this study is to compare the outcome of primary anatomic shoulder arthroplasty using the Stryker ReUnion system with implantation of either a peg or keel glenoid construction.
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:
- Subjects willing to sign the informed consent.
- Male and female subjects ages 18 – 90 at the time of surgery.
- Subjects indicated for an anatomic total shoulder arthroplasty (including primary glenohumeral osteoarthritis, avascular necrosis, and inflammatory arthritis).
Exclusion Criteria:
- Inability to comply with follow-up requirements.
- Known or presumed substantial rotator cuff disorders.
- Subjects with an active or suspected latent infection in or about the shoulder.
- Subjects with instability (surgically or non-surgically addressed).
- Subjects presenting with posttraumatic avascular necrosis.
- Need for glenoid bone grafting.
- Pregnant subjects.
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