MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.

Study Overview
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Brief Summary
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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
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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.

Official Title
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MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MOON Shoulder Instability<br>Patients indicated for Shoulder Instability surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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instability