MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.
- Conditions
- Other Instability, ShoulderSubluxationsDislocationsRecurrent Dislocation of Shoulder Region
- Registration Number
- NCT02075775
- Lead Sponsor
- Carolyn M Hettrich
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2500
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
- Workers compensation patients
- Prisoners
- Non-English speaker
- Not mentally competent
- Unable/unwilling to return for clinical follow-up
- Arthroplasty patients
- Rotator cuff tears
- Fractures
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Predictors of worse patient outcomes (pain and/or reduced quality of life). 2 years, 6 years, 10 years and 20 years Patients will fill out PRO's after surgery
- Secondary Outcome Measures
Name Time Method Predictors for recurrent instability 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
Trial Locations
- Locations (11)
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Colorado
🇺🇸Boulder, Colorado, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Orthopedic Institute
🇺🇸Sioux Falls, South Dakota, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
UCSF Orthopedic Institute
🇺🇸San Francisco, California, United States