MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:12 - 99
Updated:11/1/2018
Start Date:August 2012
End Date:August 2037
Contact:Shannon F Ortiz, MPH
Email:shannon-ortiz@uiowa.edu
Phone:319-467-8108

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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.

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.

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
We found this trial at
10
sites
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Brian Wolf, MD, MS
Phone: 319-467-8316
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Bruce S Miller, MD
Phone: 734-647-0050
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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Boulder, Colorado 80304
Principal Investigator: Eric McCarty, MD
Phone: 303-441-2175
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Boulder, CO
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Grant L Jones, MD
Phone: 614-293-7952
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Carolyn M Hettrich, MD, MPH
Phone: 859-323-5533
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Lexington, KY
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: John E Kuhn, MD
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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535 E 70th St
New York, New York 10021
(212) 606-1000
Principal Investigator: Robert G Marx, MD
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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New York, NY
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Saint Louis, Missouri 63110
Principal Investigator: Robert H Brophy, MD
Phone: 314-362-3768
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Saint Louis, MO
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San Francisco, California
Principal Investigator: Benjamin C Ma, MD
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San Francisco, CA
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Sioux Falls, South Dakota 57105
Principal Investigator: Keith Baumgarten
Phone: 605-977-6848
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Sioux Falls, SD
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