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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Iowa
Sponsor:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT02075775
First received: February 27, 2014
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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. The subject questionnaires will be completed over a series of timepoints and the subject's information from the subjects' electronic medical record will be abstracted for research data at various timepoints as well. Patients will wear a sling post-operatively, and follow standardized rehabilitation protocols, including physical therapy.


Condition
Shoulder Instability
Dislocations
Subluxations
Recurrent Shoulder Instability Surgery

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • risk factors for recurrent shoulder instability [ Time Frame: up to 20 years ] [ Designated as safety issue: No ]
    Patients will fill out questionnaires at the following time points after the initial surgery: 2 years, 6 years, 10 years and 20 years.


Secondary Outcome Measures:
  • risk factors for surgery failure (recurrent shoulder instability surgery [ Time Frame: 2 years, 6 years, 10 years and 20 years ] [ Designated as safety issue: No ]
    Patients will fill out questionnaires at the following time points after the initial surgery: 2 years, 6 years, 10 years and 20 years.


Other Outcome Measures:
  • risk factors for poor post-operative outcomes (pain and/or reduced quaility of life). [ Time Frame: 2 years, 6 years, 10 years and 20 years ] [ Designated as safety issue: No ]
    Patients will fill out questionnaires at the following time points after the initial surgery: 2 years, 6 years, 10 years and 20 years.


Estimated Enrollment: 10000
Study Start Date: August 2012
Estimated Study Completion Date: August 2037
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients indicated for Shoulder Instability surgery

Detailed Description:

Participants will complete the MOON Shoulder Instability patient form to document shoulder function and overall health status. The questionnaire will take 20-30 minutes to complete. The patient questionnaire will be completed once in the clinic before surgery and then will be mailed to them at 2 years, 6 years, 10 years and 20 years after surgery. An additional pre-surgical questionnaire will be completed on-line and will become part of the participant's UIHC electronic medical record. This is the standard of care for all shoulder instability patients in the Sports Medicine Clinic, regardless of study participation. Reviewing the noted pre-surgical questionnaire will be a review of data collected as part of clinical activity and is not considered a research-initiated data collection. Study-specific information, such as follow-up contact information, will be collected at this time. The follow-up questionnaires will be mailed to participants with a postage-paid return envelope by the coordinating center at University of Iowa. The coordinating center will also call participants prior to mailing follow-up questionnaires to confirm that the mailing information is correct and to ascertain whether the participant has had any subsequent shoulder surgery. At the two, six, ten, and twenty year time-points the participant's local medical record will be queried to identify any subsequent shoulder surgery occurring at the University of Iowa Hospital and Clinics. Physicians will complete an initial evaluation form detailing range of motion and radiologic imaging information when the patient is indicated for surgery. They will complete an in depth evaluation form detailing specific pathologies of the shoulder and any operative findings at the time of surgery. Finally at the 4-6 month time point following surgery the physician will complete a clinical follow up form on range of motion and shoulder function.

Additionally, for recruitment purposes, we will need to obtain potential subjects' demographic data, as well as any information related to the diagnosis and treatment of their shoulder instability, from their medical record. This information will be obtained from potential subjects' medical records prior to consent has been given. We will review subjects' medical record at each of the follow-up timepoints (4-6 months, and 2, 6, 10, and 20 years) for updated demographic information, as well as information related specifically to their diagnosis of shoulder instability. This may include information about the initial surgery, as well as subsequent shoulder surgeries, complications, additional treatment and physical therapy notes, x-rays or other images, and outcome measures for pain and functionality.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Potential subjects are patients who have been diagnosed with shoulder instability injuries.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: C Benjamin Ma, MD         
Principal Investigator: Brian T Feeley, MD         
Sub-Investigator: Christina R Allen, 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: Armando F Vidal, MD         
Principal Investigator: Jonathan T Bravman, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Shannon F Ortiz, MPH    319-467-8108    shannon-ortiz@uiowa.edu   
Principal Investigator: Carolyn Hettrich, MD, MPH         
Principal Investigator: Brian Wolf, MD, MS         
Sub-Investigator: Matthew Bollier, MD         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109-0328
Contact: Jaimee Gauthier    734-647-0050    jaineeg@umich.edu   
Principal Investigator: Bruce S Miller, MD         
Principal Investigator: James E Carpenter, MD         
United States, Missouri
Washington University Recruiting
St. 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         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Shannon Marcoon    215-615-4439    shannon-marcoon@uphs.upenn.edu   
Principal Investigator: James L Carey, MD         
Principal Investigator: John D Kelly, MD         
Principal Investigator: Brian J Sennett, MD         
United States, South Dakota
Orthopedic Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Cynde Jervik    605-977-6848    cjervik@ortho-i.com   
Principal Investigator: Keith Baumgarten         
United States, Tennessee
Knoxville Orthopedic Clinic Not yet recruiting
Knoxville, Tennessee, United States
Principal Investigator: Edwin E Spencer, MD         
Principal Investigator: G Brian Holloway, MD         
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232-8774
Contact: Rosemary Sanders, BA, CCRP         
Principal Investigator: John E Kuhn, MD         
Principal Investigator: Charlie Cox, MD         
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Carolyn M Hettrich, MD, MPH University of Iowa
Principal Investigator: Brian Wolf, MD, MS University of Iowa
  More Information

No publications provided

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT02075775     History of Changes
Other Study ID Numbers: MOON SI 2013
Study First Received: February 27, 2014
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
instability

Additional relevant MeSH terms:
Dislocations
Wounds and Injuries

ClinicalTrials.gov processed this record on July 24, 2014