RECRUITING

MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.

Quick Facts

Study Start:2012-08
Study Completion:2042-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02075775

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Workers compensation patients
  2. * Prisoners
  3. * Non-English speaker
  4. * Not mentally competent
  5. * Unable/unwilling to return for clinical follow-up
  6. * Arthroplasty patients
  7. * Rotator cuff tears
  8. * Fractures

Contacts and Locations

Study Contact

Shannon F Ortiz, MPH
CONTACT
319-467-8316
shannon-ortiz@uiowa.edu
Armand Gentile
CONTACT
319-467-8324
armand-gentile@uiowa.edu

Principal Investigator

Carolyn M Hettrich, MD, MPH
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Brian Wolf, MD, MS
PRINCIPAL_INVESTIGATOR
University of Iowa

Study Locations (Sites)

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
Saint 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

Collaborators and Investigators

Sponsor: Carolyn M Hettrich

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-08
Study Completion Date2042-12

Study Record Updates

Study Start Date2012-08
Study Completion Date2042-12

Terms related to this study

Keywords Provided by Researchers

  • instability

Additional Relevant MeSH Terms

  • Other Instability, Shoulder
  • Dislocations
  • Subluxations
  • Recurrent Dislocation of Shoulder Region