RecruitingNCT02075775

MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.


Sponsor

Carolyn M Hettrich

Enrollment

2,500 participants

Start Date

Aug 1, 2012

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 99 Years

Inclusion Criteria6

  • 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

Exclusion Criteria8

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

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Locations(11)

UCSF Orthopedic Institute

San Francisco, California, United States

University of Colorado

Boulder, Colorado, United States

University of Iowa

Iowa City, Iowa, United States

University of Kentucky

Lexington, Kentucky, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Washington University

St Louis, Missouri, United States

Hospital for Special Surgery

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

Orthopedic Institute

Sioux Falls, South Dakota, United States

Vanderbilt University

Nashville, Tennessee, United States

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NCT02075775