Clincosm LogoSign in Get a demo

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

Sponsor
Carolyn M Hettrich (Other)
Overall Status
Recruiting
CT.gov ID
NCT02075775
Collaborator
University of Michigan (Other), University of California, San Francisco (Other), University of Kentucky (Other), Hospital for Special Surgery, New York (Other), University of Colorado, Denver (Other), Ohio State University (Other), Washington University School of Medicine (Other), Orthopedic Institute, Sioux Falls, SD (Other), Vanderbilt University (Other), Brigham and Women's Hospital (Other)
2,500
Enrollment
11
Locations
300
Anticipated Duration (Months)
227.3
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.
    Actual Study Start Date :
    Aug 1, 2012
    Anticipated Primary Completion Date :
    Jul 1, 2020
    Anticipated Study Completion Date :
    Aug 1, 2037

    Arms and Interventions

    Arm Intervention/Treatment
    MOON Shoulder Instability

    Patients indicated for Shoulder Instability surgery

    Outcome Measures

    Primary Outcome Measures

    1. Predictors of worse patient outcomes (pain and/or reduced quality of life). [2 years, 6 years, 10 years and 20 years]

      Patients will fill out PRO's after surgery

    Secondary Outcome Measures

    1. Predictors for recurrent instability [2 years, 6 years, 10 years and 20 years]

      Patients will be asked if they have had repeat surgery, recurrent dislocation, subluxation, as well as symptoms of instability on WOSI

    Other Outcome Measures

    1. Predictors of shoulder osteoarthritis [6 years, 10 years and 20 years]

      Patients will fill out PRO's, symptomatic may return for xrays

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCSF Orthopedic Institute San Francisco California United States 94158
    2 University of Colorado Boulder Colorado United States 80304
    3 University of Iowa Iowa City Iowa United States 52242
    4 University of Kentucky Lexington Kentucky United States 40536
    5 Brigham and Women's Hospital Boston Massachusetts United States
    6 University of Michigan Ann Arbor Michigan United States 48109-0328
    7 Washington University Saint Louis Missouri United States 63110
    8 Hospital for Special Surgery New York New York United States 10021
    9 Ohio State University Columbus Ohio United States 43221
    10 Orthopedic Institute Sioux Falls South Dakota United States 57105
    11 Vanderbilt University Nashville Tennessee United States 37232-8774

    Sponsors and Collaborators

    • Carolyn M Hettrich
    • University of Michigan
    • University of California, San Francisco
    • University of Kentucky
    • Hospital for Special Surgery, New York
    • University of Colorado, Denver
    • Ohio State University
    • Washington University School of Medicine
    • Orthopedic Institute, Sioux Falls, SD
    • Vanderbilt University
    • Brigham and Women's Hospital

    Investigators

    • Principal Investigator: Carolyn M Hettrich, MD, MPH, Brigham and Women's Hospital
    • Principal Investigator: Brian Wolf, MD, MS, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carolyn M Hettrich, Associate Professor, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT02075775
    Other Study ID Numbers:
    • 201208835
    First Posted:
    Mar 3, 2014
    Last Update Posted:
    Jan 29, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Carolyn M Hettrich, Associate Professor, University of Iowa
    instability
    Additional relevant MeSH terms:
    Joint Dislocations
    Shoulder Dislocation

    Study Results

    No Results Posted as of Jan 29, 2020