MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.
MOONSI
1 other identifier
observational
1,733
1 country
11
Brief Summary
This project will be a multi-center, prospective longitudinal cohort for all patients undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will be looking for risk factors for recurrent instability, revision surgery, and poor outcomes. Patients will be asked to complete the RAND-36, ASES, Shoulder Activity, EQ-5D and WOSI outcome measures, as well as demographic and socioeconomic information. Surgeons will complete a form after surgery with information on radiographic findings, physical exam, surgical findings, and the repair. Patients will wear a sling post-operatively, and follow standardized rehabilitation protocols, including physical therapy. Patients will be sent outcome questionnaires at 2, 6, 10, and 20 years after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2012
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 27, 2014
CompletedFirst Posted
Study publicly available on registry
March 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2042
April 8, 2026
April 1, 2026
20.4 years
February 27, 2014
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Predictors of worse patient outcomes (pain and/or reduced quality of life).
Patients will fill out PRO's after surgery
2 years, 6 years, 10 years and 20 years
Secondary Outcomes (1)
Predictors for recurrent instability
2 years, 6 years, 10 years and 20 years
Other Outcomes (1)
Predictors of shoulder osteoarthritis
6 years, 10 years and 20 years
Study Arms (1)
MOON Shoulder Instability
Patients indicated for Shoulder Instability surgery
Eligibility Criteria
Potential subjects are patients who are undergoing surgery of the labrum and/or capsule for shoulder instability
You may qualify if:
- This is a prospective cohort study; there is no control group. Subjects that are included are all patients undergoing surgery for shoulder instability.
- Anterior, posterior, and inferior instability
- Ages 12-99
- Open and arthroscopic repair
- Revision of a previous shoulder instability repair
- Latarjet/bone augmentation
You may not qualify if:
- Workers compensation patients
- Prisoners
- Non-English speaker
- Not mentally competent
- Unable/unwilling to return for clinical follow-up
- Arthroplasty patients
- Rotator cuff tears
- Fractures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carolyn M Hettrichlead
- University of Michigancollaborator
- University of California, San Franciscocollaborator
- University of Kentuckycollaborator
- Hospital for Special Surgery, New Yorkcollaborator
- University of Colorado, Denvercollaborator
- Ohio State Universitycollaborator
- Washington University School of Medicinecollaborator
- Orthopedic Institute, Sioux Falls, SDcollaborator
- Vanderbilt Universitycollaborator
- Brigham and Women's Hospitalcollaborator
Study Sites (11)
UCSF Orthopedic Institute
San Francisco, California, 94158, United States
University of Colorado
Boulder, Colorado, 80304, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109-0328, United States
Washington University
St Louis, Missouri, 63110, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Ohio State University
Columbus, Ohio, 43221, United States
Orthopedic Institute
Sioux Falls, South Dakota, 57105, United States
Vanderbilt University
Nashville, Tennessee, 37232-8774, United States
Related Publications (3)
Hettrich CM, Magnuson JA, Baumgarten KM, Brophy RH, Kattan M; MOON Shoulder Group; Bishop JY, Bollier MJ, Bravman JT, Cvetanovich GL, Dunn WR, Feeley BT, Frank RM, Kuhn JE, Lansdown DA, Benjamin Ma C, Marx RG, McCarty EC, Neviaser AS, Ortiz SF, Seidl AJ, Smith MV, Wright RW, Zhang AL, Cronin KJ, Wolf BR. Predictors of Bone Loss in Anterior Glenohumeral Instability. Am J Sports Med. 2023 Apr;51(5):1286-1294. doi: 10.1177/03635465231160286. Epub 2023 Mar 20.
PMID: 36939180DERIVEDBrophy RH, Dunn WR; MOON Shoulder Group; Baumgarten KM, Bishop JY, Bollier MJ, Bravman JT, Feeley BT, Grant JA, Jones GL, Kuhn JE, Benjamin Ma C, Marx RG, McCarty EC, Ortiz SF, Smith MV, Wolf BR, Wright RW, Zhang AL, Hettrich CM. Factors Associated With Shoulder Activity Level at Time of Surgery and at 2-Year Follow-up in Patients Undergoing Shoulder Stabilization Surgery. Am J Sports Med. 2022 May;50(6):1503-1511. doi: 10.1177/03635465221085978. Epub 2022 Apr 20.
PMID: 35442106DERIVEDBaron JE, Duchman KR, Hettrich CM, Glass NA, Ortiz SF; MOON Shoulder Group; Baumgarten KM, Bishop JY, Bollier MJ, Bravman JT, Brophy RH, Carpenter JE, Cox CL, Feeley BT, Frank RM, Grant JA, Jones GL, Kuhn JE, Lansdown DA, Benjamin Ma C, Marx RG, McCarty EC, Miller BS, Neviaser AS, Seidl AJ, Smith MV, Wright RW, Zhang AL, Wolf BR. Beach Chair Versus Lateral Decubitus Position: Differences in Suture Anchor Position and Number During Arthroscopic Anterior Shoulder Stabilization. Am J Sports Med. 2021 Jul;49(8):2020-2026. doi: 10.1177/03635465211013709. Epub 2021 May 21.
PMID: 34019439DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn M Hettrich, MD, MPH
Brigham and Women's Hospital
- PRINCIPAL INVESTIGATOR
Brian Wolf, MD, MS
University of Iowa
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 20 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 27, 2014
First Posted
March 3, 2014
Study Start
August 1, 2012
Primary Completion (Estimated)
December 31, 2032
Study Completion (Estimated)
December 1, 2042
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share