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

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ClinicalTrials.gov Identifier: NCT02075775
Recruitment Status : Recruiting
First Posted : March 3, 2014
Last Update Posted : May 4, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Carolyn M Hettrich, University of Kentucky

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
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 [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.
Actual Study Start Date : August 2012
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2037

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



Primary Outcome Measures :
  1. Predictors of worse patient outcomes (pain and/or reduced quaility of life). [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 years, 10 years and 20 years ]
    Patients will fill out PRO's, symptomatic may return for xrays



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Ages Eligible for Study:   12 Years to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential subjects are patients who are undergoing surgery of the labrum and/or capsule for shoulder instability
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075775


Contacts
Contact: Shannon F Ortiz, MPH 319-467-8108 shannon-ortiz@uiowa.edu
Contact: Armand Gentile 319-467-8324 armand-gentile@uiowa.edu

Locations
United States, California
UCSF Orthopedic Institute Recruiting
San Francisco, California, United States, 94158
Contact: Sarah Hall         
Principal Investigator: Benjamin C Ma, MD         
Sub-Investigator: Brian T Feeley, MD         
Sub-Investigator: Alan Zhang, MD         
United States, Colorado
University of Colorado Recruiting
Boulder, Colorado, United States, 80304
Contact: Cyndi Long    303-441-2175    cyndi.long@ucdenver.edu   
Principal Investigator: Eric McCarty, MD         
Principal Investigator: Jonathan T Bravman, MD         
Sub-Investigator: Adam Siedl, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Shannon F Ortiz, MPH    319-467-8316    shannon-ortiz@uiowa.edu   
Principal Investigator: Brian Wolf, MD, MS         
Sub-Investigator: Matthew Bollier, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Cale A Jacobs, PhD    859-323-5533    cale.jacobs@uky.edu   
Principal Investigator: Carolyn M Hettrich, MD, MPH         
Sub-Investigator: Scott Mair, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-0328
Contact: Jaimee Gauthier    734-647-0050      
Principal Investigator: Bruce S Miller, MD         
Principal Investigator: James E Carpenter, MD         
Sub-Investigator: John Grant, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Amanda Haas, MA    314-362-3768    haasa@wudosis.wustl.edu   
Principal Investigator: Robert H Brophy, MD         
Principal Investigator: Rick W Wright, MD         
Principal Investigator: Matthew V Smith, MD         
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Nabil Mehta         
Principal Investigator: Robert G Marx, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: Angela Pedroza, MPH    614-293-7952    angela.pedroza@osumc.edu   
Principal Investigator: Grant L Jones, MD         
Principal Investigator: Julie Y Bishop, MD         
Principal Investigator: Andrew Neviaser, MD         
United States, South Dakota
Orthopedic Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Jillian Doty    605-977-6848      
Principal Investigator: Keith Baumgarten         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232-8774
Contact: Brooke Rode         
Principal Investigator: John E Kuhn, MD         
Principal Investigator: Charlie Cox, MD         
Sponsors and Collaborators
University of Iowa
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
Investigators
Principal Investigator: Carolyn M Hettrich, MD, MPH University of Kentucky
Principal Investigator: Brian Wolf, MD, MS University of Iowa

Responsible Party: Carolyn M Hettrich, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT02075775     History of Changes
Other Study ID Numbers: 201208835
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Carolyn M Hettrich, University of Kentucky:
instability

Additional relevant MeSH terms:
Joint Dislocations
Shoulder Dislocation
Recurrence
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries
Disease Attributes
Pathologic Processes