Observational study on patients undergoing shoulder instability surgery

MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.

This study is looking at patients who have shoulder instability surgery to see what factors might affect their recovery and chances of needing more surgery later on.

Quick facts

• Study type: Observational
• Enrollment: 2500 (estimated)
• Ages: 12 Years to 99 Years
• Sex: All
• Sponsor: University of Iowa (other)
• Locations: 11 sites (San Francisco, California and 10 other locations)
• Trial ID: NCT02075775 on ClinicalTrials.gov

What this trial studies

This observational study aims to create a multi-center, prospective longitudinal cohort of patients undergoing primary surgery for shoulder instability, excluding isolated SLAP repairs. The study will collect data on risk factors for recurrent instability, revision surgery, and overall outcomes through various validated outcome measures and demographic information. Patients will complete questionnaires at multiple time points post-surgery, while surgeons will provide detailed surgical and radiographic findings. The goal is to identify predictors of sports function, activity level, and surgical failures following the procedure.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 12-99 undergoing surgery for anterior, posterior, or inferior shoulder instability.

Not a fit: Patients with rotator cuff tears, fractures, or those requiring arthroplasty will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve understanding of factors influencing outcomes after shoulder instability surgery, leading to better patient care and surgical techniques.

How similar studies have performed: Other studies have shown success in identifying predictors of outcomes in similar surgical populations, suggesting this approach is promising.

Eligibility 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

Where this trial is running

San Francisco, California and 10 other locations

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

Study contacts

• Principal investigator: Carolyn M Hettrich, MD, MPH — Brigham and Women's Hospital
• Study coordinator: Shannon F Ortiz, MPH

Conditions: Other Instability, Shoulder, Dislocations, Subluxations, Recurrent Dislocation of Shoulder Region, instability