MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Other Instability, Shoulder Dislocations Joint Diseases Joint Dislocations Musculoskeletal Diseases Recurrent Dislocation of Shoulder Region Subluxations Wounds and Injuries

Age range

12 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Orthopedic Institute, San Francisco, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Predictors of worse patient outcomes (pain and/or reduced quality of life).

Time frame: 2 years, 6 years, 10 years and 20 years

Patients will fill out PRO's after surgery

Secondary outcomes

Predictors for recurrent instability

Time frame: 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

Other outcomes

Predictors of shoulder osteoarthritis

Time frame: 6 years, 10 years and 20 years

Patients will fill out PRO's, symptomatic may return for xrays

Sponsors and collaborators

Lead sponsor

Carolyn M Hettrich

Other

Collaborators

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

Registry information

Acronym: MOONSI

Important dates

Study start: 2012
Primary completion: 2032
Study completion: 2042
First posted: Mar 3, 2014
Registry last updated: Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed