MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.

Dislocations Clinical Trial

— MOONSI  

Official title:

MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02075775
• Other study ID #: 201208835
• Status: Recruiting
• Start date: August 2012
• Est. completion date: December 2042

Study information

• Verified date: November 2022
• Source: University of Iowa
• Contact: Shannon F Ortiz, MPH
• Phone: 319-467-8316
• Email: shannon-ortiz[@]uiowa.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 2042
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Colorado	Boulder	Colorado
United States	Ohio State University	Columbus	Ohio
United States	University of Iowa	Iowa City	Iowa
United States	University of Kentucky	Lexington	Kentucky
United States	Vanderbilt University	Nashville	Tennessee
United States	Hospital for Special Surgery	New York	New York
United States	Washington University	Saint Louis	Missouri
United States	UCSF Orthopedic Institute	San Francisco	California
United States	Orthopedic Institute	Sioux Falls	South Dakota

Sponsors (11)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Predictors of shoulder osteoarthritis	Patients will fill out PRO's, symptomatic may return for xrays	6 years, 10 years and 20 years
Primary	Predictors of worse patient outcomes (pain and/or reduced quality of life).	Patients will fill out PRO's after surgery	2 years, 6 years, 10 years and 20 years
Secondary	Predictors for recurrent instability	Patients will be asked if they have had repeat surgery, recurrent dislocation, subluxation, as well as symptoms of instability on WOSI	2 years, 6 years, 10 years and 20 years