MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment. (MOONSI)

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.

Study Overview

• Status: Recruiting
• Conditions: Other Instability, Shoulder; Dislocations; Subluxations; Recurrent Dislocation of Shoulder Region

Detailed Description

The objective of this prospective multicenter cohort study of patients undergoing surgery for glenohumeral instability is to identify the outcomes, and more importantly, the previously unknown predictors of sports function, activity level, general health, recurrent instability symptoms, and surgical failures following surgery. Patient information at the time of the surgery (demographics, validated outcome measures), in addition to the physical exam findings, shoulder pathology at the time of surgery, and surgical treatment will be obtained. The validated outcome instruments are American Shoulder and Elbow Surgeons Score, Western Ontario Shoulder Instability, Kerlan Jobe Overhand Athlete Score, Shoulder Activity Score, and RAND-36. Post-operative physical exam data will be obtained at 6 months after surgery. Patient reported outcomes will be repeated at 2, 6, 10, and 20 years post-operatively. Our multivariable analysis will identify which of the many factors related to the injury, intra-operative treatment, postoperative care, physical patient characteristics, and behavioral patient characteristics contribute to recurrence and poor outcome.

• Study Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: Shannon F Ortiz, MPH; Phone Number: 319-467-8316; Email: shannon-ortiz@uiowa.edu
• Study Contact Backup: Name: Armand Gentile; Phone Number: 319-467-8324; Email: armand-gentile@uiowa.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • Recruiting
      • UCSF Orthopedic Institute
      • Contact: Mya Sandi Aung; Phone Number: 415-514-6120; Email: myasandi.aung@ucsf.edu
      • Principal Investigator: Benjamin C Ma, MD
      • Sub-Investigator: Brian T Feeley, MD
      • Sub-Investigator: Alan Zhang, MD
      • Sub-Investigator: Drew A Lansdown, MD
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Recruiting
      • University of Colorado
      • Contact: Darby Houch, BA; Phone Number: 303-315-9928; Email: darby.houck@cuanschutz.edu
      • Principal Investigator: Jonathan T Bravman, MD
      • Sub-Investigator: Adam Siedl, MD
      • Sub-Investigator: Rachel M Frank, MD
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
      • Contact: Shannon F Ortiz, MPH; Phone Number: 319-467-8316; Email: shannon-ortiz@uiowa.edu
      • Principal Investigator: Brian Wolf, MD, MS
      • Sub-Investigator: Matthew Bollier, MD
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky
      • Contact: Cale A Jacobs, PhD; Phone Number: 859-323-5533; Email: cale.jacobs@uky.edu
      • Principal Investigator: Carolyn M Hettrich, MD, MPH
      • Sub-Investigator: Scott Mair, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Principal Investigator: Carolyn M Hettrich, MD, MPH
      • Contact: Jhillika Patel; Phone Number: 609-271-8392; Email: jpatel41@bwh.harvard.edu
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0328
      • Recruiting
      • University of Michigan
      • Contact: Bethany Ruffino, LPN, CCRP; Phone Number: 734-615-0768; Email: bruffino@med.umich.edu
      • Principal Investigator: Bruce S Miller, MD
      • Sub-Investigator: James E Carpenter, MD
      • Sub-Investigator: John A. Grant, MD
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University
      • Contact: Amanda Braun, MA; Phone Number: 314-362-3768; Email: ahaas22@wustl.edu
      • Principal Investigator: Robert H Brophy, MD
      • Sub-Investigator: Rick W Wright, MD
      • Principal Investigator: Matthew V Smith, MD
  • New York
    • New York, New York, United States, 10021
      • Active, not recruiting
      • Hospital for Special Surgery
  • Ohio
    • Columbus, Ohio, United States, 43221
      • Recruiting
      • Ohio State University
      • Contact: Yazen Qaisi; Phone Number: 614-366-7598; Email: yazen.qaisi@osumc.edu
      • Principal Investigator: Grant L Jones, MD
      • Principal Investigator: Julie Y Bishop, MD
      • Principal Investigator: Andrew Neviaser, MD
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Recruiting
      • Orthopedic Institute
      • Contact: Jillian Doty; Phone Number: 605-977-6848
      • Principal Investigator: Keith Baumgarten
  • Tennessee
    • Nashville, Tennessee, United States, 37232-8774
      • Recruiting
      • Vanderbilt University
      • Contact: Brooke Rode
      • Principal Investigator: John E Kuhn, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 99 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Potential subjects are patients who are undergoing surgery of the labrum and/or capsule for shoulder instability

Description

Inclusion Criteria:

This is a prospective cohort study; there is no control group. Subjects that are included are all patients undergoing surgery for shoulder instability.

Inclusion criteria:

• Anterior, posterior, and inferior instability
• Ages 12-99
• Open and arthroscopic repair
• Revision of a previous shoulder instability repair
• Latarjet/bone augmentation

Exclusion Criteria:

• Workers compensation patients
• Prisoners
• Non-English speaker
• Not mentally competent
• Unable/unwilling to return for clinical follow-up
• Arthroplasty patients
• Rotator cuff tears
• Fractures

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MOON Shoulder Instability; Patients indicated for Shoulder Instability surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors for recurrent instability	Patients will be asked if they have had repeat surgery, recurrent dislocation, subluxation, as well as symptoms of instability on WOSI	2 years, 6 years, 10 years and 20 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors of shoulder osteoarthritis	Patients will fill out PRO's, symptomatic may return for xrays	6 years, 10 years and 20 years

Collaborators and Investigators

• Sponsor: Carolyn M Hettrich
• Collaborators: University of Colorado, Denver; Washington University School of Medicine; University of Michigan; Brigham and Women's Hospital; University of California, San Francisco; Vanderbilt University; Ohio State University; Hospital for Special Surgery, New York; University of Kentucky; Orthopedic Institute, Sioux Falls, SD
• Investigators: Principal Investigator: Carolyn M Hettrich, MD, MPH, Brigham and Women's Hospital; Principal Investigator: Brian Wolf, MD, MS, University of Iowa

Publications and helpful links

General Publications

• Brophy 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.
• Baron 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2012
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 1, 2042

Study Registration Dates

• First Submitted: February 27, 2014
• First Submitted That Met QC Criteria: February 28, 2014
• First Posted (ESTIMATE): March 3, 2014

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: instability
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: 201208835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO