MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.

NCT ID: NCT02075775

Last Updated: 2022-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2042-12-31

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.

Conditions

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Other Instability, Shoulder Dislocations Subluxations Recurrent Dislocation of Shoulder Region

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MOON Shoulder Instability

Patients indicated for Shoulder Instability surgery

No interventions assigned to this group

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.


* 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
Minimum Eligible Age

12 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

University of Kentucky

OTHER

Sponsor Role collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

Orthopedic Institute, Sioux Falls, SD

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Carolyn M Hettrich

OTHER

Sponsor Role lead

Responsible Party

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Carolyn M Hettrich

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Carolyn M Hettrich, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Brian Wolf, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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UCSF Orthopedic Institute

San Francisco, California, United States

Site Status RECRUITING

University of Colorado

Boulder, Colorado, United States

Site Status RECRUITING

University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

University of Kentucky

Lexington, Kentucky, United States

Site Status RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Washington University

St Louis, Missouri, United States

Site Status RECRUITING

Hospital for Special Surgery

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Orthopedic Institute

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Vanderbilt University

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shannon F Ortiz, MPH

Role: CONTACT

319-467-8316

Armand Gentile

Role: CONTACT

319-467-8324

Facility Contacts

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Mya Sandi Aung

Role: primary

415-514-6120

Darby Houch, BA

Role: primary

303-315-9928

Shannon F Ortiz, MPH

Role: primary

319-467-8316

Cale A Jacobs, PhD

Role: primary

859-323-5533

Jhillika Patel

Role: primary

609-271-8392

Bethany Ruffino, LPN, CCRP

Role: primary

734-615-0768

Amanda Braun, MA

Role: primary

314-362-3768

Yazen Qaisi

Role: primary

614-366-7598

Jillian Doty

Role: primary

605-977-6848

Brooke Rode

Role: primary

References

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Hettrich CM, Magnuson JA, Baumgarten KM, Brophy RH, Kattan M; MOON Shoulder Group; Bishop JY, Bollier MJ, Bravman JT, Cvetanovich GL, Dunn WR, Feeley BT, Frank RM, Kuhn JE, Lansdown DA, Benjamin Ma C, Marx RG, McCarty EC, Neviaser AS, Ortiz SF, Seidl AJ, Smith MV, Wright RW, Zhang AL, Cronin KJ, Wolf BR. Predictors of Bone Loss in Anterior Glenohumeral Instability. Am J Sports Med. 2023 Apr;51(5):1286-1294. doi: 10.1177/03635465231160286. Epub 2023 Mar 20.

Reference Type DERIVED
PMID: 36939180 (View on PubMed)

Brophy RH, Dunn WR; MOON Shoulder Group; Baumgarten KM, Bishop JY, Bollier MJ, Bravman JT, Feeley BT, Grant JA, Jones GL, Kuhn JE, Benjamin Ma C, Marx RG, McCarty EC, Ortiz SF, Smith MV, Wolf BR, Wright RW, Zhang AL, Hettrich CM. Factors Associated With Shoulder Activity Level at Time of Surgery and at 2-Year Follow-up in Patients Undergoing Shoulder Stabilization Surgery. Am J Sports Med. 2022 May;50(6):1503-1511. doi: 10.1177/03635465221085978. Epub 2022 Apr 20.

Reference Type DERIVED
PMID: 35442106 (View on PubMed)

Baron JE, Duchman KR, Hettrich CM, Glass NA, Ortiz SF; MOON Shoulder Group; Baumgarten KM, Bishop JY, Bollier MJ, Bravman JT, Brophy RH, Carpenter JE, Cox CL, Feeley BT, Frank RM, Grant JA, Jones GL, Kuhn JE, Lansdown DA, Benjamin Ma C, Marx RG, McCarty EC, Miller BS, Neviaser AS, Seidl AJ, Smith MV, Wright RW, Zhang AL, Wolf BR. Beach Chair Versus Lateral Decubitus Position: Differences in Suture Anchor Position and Number During Arthroscopic Anterior Shoulder Stabilization. Am J Sports Med. 2021 Jul;49(8):2020-2026. doi: 10.1177/03635465211013709. Epub 2021 May 21.

Reference Type DERIVED
PMID: 34019439 (View on PubMed)

Other Identifiers

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201208835

Identifier Type: -

Identifier Source: org_study_id

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