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John E. Kuhn, MD Tara T. Holmes, PA-C, MPH. ?. What is. MOON - Multicenter Orthopaedic Outcome Network. MOON Knee, est. in 2001, is a consortium of 7 sites and 17 surgeons studying outcomes following anterior cruciate ligament reconstruction.

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slide1

John E. Kuhn, MD

Tara T. Holmes, PA-C, MPH

slide2

?

What is

  • MOON - Multicenter Orthopaedic Outcome Network.
  • MOON Knee, est. in 2001, is a consortium of 7 sites
  • and 17 surgeons studying outcomes following anterior
  • cruciate ligament reconstruction.
  • MOON Shoulder, est. in 2004 and modeled after
  • MOON Knee, is a consortium of 9 sites and 17 surgeons
  • studying disorders of the shoulder
  • Vanderbilt Sports Medicine functions as the Coordinating
  • Center for MOON.
moon shoulder

MOON Shoulder

Ultimate Goal: Study Features that Influence Success of Rotator Cuff Repair

slide5

MOON Shoulder Consortium: 9 Sites - 17 Surgeons

Vanderbilt Orthopaedic Institute

Warren R. Dunn, MD, MPH

John E. Kuhn, MD

Kurt P. Spindler, MD

James Carey, MD

Washington University – St. Louis

Rick W. Wright, MD

Robert Brophy, MD

University of Colorado

Eric C. McCarty, MD

Armando F. Vidal, MD

University of Iowa

Brian R. Wolf, MD, MS

Hospital for Special Surgery

Robert G. Marx, MD, MSc, FRCSC

Ohio State University

Grant L. Jones, MD

Julie Y. Bishop, MD

David C. Flanigan, MD

University of California at San Francisco

C. Benjamin Ma, MD

Orthopedic Institute

Keith M. Baumgarten, MD

Knoxville Orthopedic Clinic

Edwin E. Spencer Jr, MD

Brian Holloway, MD

slide6

Participating Sites: Support Staff

Orthopedic Institute

Kari Caspers

Dayna Semchenko, PA-C

Patrick Heiser, PA-C

University of Iowa

Carla Britton

Andrea Wilson, PA-C

Ohio State University

Angela Pedroza

Melissa Bowlby

Justin Long

Wendy McGeehan

Hospital for Special Surgery

Jessica Ryu

University of California

at San Francisco

Emily Keifa

Knoxville Orthopedic Clinic

Lori Sharp, PA-C

Mary Cate

Andrea Parton

University of Colorado

Paula Langner

Washington University – St. Louis

Linda Burnworth

Michele Cooper

This research would not

be possible without our

tremendous support staff!

slide7

Vanderbilt Sports Medicine (Coordinating Center)

Additional Research Staff

Angela Combs, RN

Angela Keen

Sarah

Editorial Assistance

Lynn Sykes Cain

Biostatistics

Frank Harrell, Ph.D

Warren R. Dunn, MD, MPH

Zhouwen Liu, MS

C. Thomas Dupont, BS

Research Coordinator

Tara T. Holmes, PA-C, MPH

Research Analyst

Brooke E. Rode

slide8

Features to Predict Success with Non-operative Treatment of Patients with Full-thickness Rotator Cuff Tears (Kuhn)

NIH 5K23AR052392-02 (Dunn)

Clinical Scholars in Epidemiology (Dunn)

slide10

Ongoing Development

  • Monthly Conference calls to review/discuss issues related to current study and to discuss additional/future studies
  • Group meets in-person three times per year
  • Manual of Operations gets reviewed and updated as necessary
phase i reducing variables
Phase I-Reducing Variables
  • Common Methods of Describing Pathology/Findings/Independent Variables
    • Validated Data Collection Forms
    • Agreement Studies
  • Common Practice Patterns
    • Criteria to Order MRI
    • Surgical Indications
    • Postoperative Care
phase ii data collection
Phase II – Data Collection
  • Prospective Cohort Study
  • 2000 patients
  • Long F/U with MRI
  • NIH Funding
  • Identify Controllable Features that Influence Failure of Rotator Cuff Repair
slide14

Shoulder

The MOON Shoulder consortium met 7 times (5/04 –

10/06) with the following goals -

  • Formulate research questions of interest for the study of rotator cuff disease
  • Develop standardized criteria for ordering an MRI
  • Develop a consensus on the standard x-ray and MRI imaging techniques
  • Select and develop outcomes instruments
consensus no data in literature
ConsensusNo Data in Literature

The MOON Shoulder consortium met 7 times (5/04 –

10/06) with the following goals -

  • Develop standardized criteria for ordering an MRI
  • Develop a consensus on the standard x-ray and MRI imaging techniques
  • Select and develop outcomes instruments
slide16

Development of Data Collection Forms and Database

Patient Form

Physical Exam Form

Surgical Data Collection Form

systematic reviews
Systematic Reviews
  • Nonoperative Physical Therapy Program
  • Surgical Indications in Treatment of Rotator Cuff Disease
  • Postoperative Care
    • Cryotherapy
    • Physical Therapy
    • CPM
original research
Original Research
  • Agreement Study on Describing MRI Findings
  • Agreement Study on Describing Intraarticular Pathology
  • Study on Nonoperative Treatment for Common Surgical Indications
slide19

Interobserver agreement studies

  • Interobserver agreement in the classification of rotator cuff tears(Kuhn et al AJSM 2007) – LOE: II
    • 12 fellowship trained orthopaedic surgeons reviewed arthroscopy videos from 30 patients and classified them using 6 different classification systems
    • Interobserver agreement determined by kappa analysis
    • High when distinguishing full-thickness from partial-thickness tears (0.95, K=0.85)
    • High when identifying the side of involvement of partial thickness tears (0.95, K=0.85)
slide20

Classification of Video Cuff Disease

  • Inter-observer agreement was high when distinguishing between full thickness and partial thickness tears (0.95, κ=0.85).
  • The investigators agreed on the side (articular vs. bursal) of involvement for partial thickness tears (observed agreement 0.92, κ=0.85), but could not agree when classifying the depth of the partial thickness tear (observed agreement 0.49, κ=0.19).
  • The best agreement for full thickness tears was seen when tear was classified by topography in the frontal plane (observed agreement 0.70, κ=0.54).
slide21

Interobserver agreement studies

  • Interobserver agreement in the classification of rotator cuff tears using magnetic resonance imaging (Spencer et al 2007 – accepted AJSM June 2007) – LOE: II
    • 10 fellowship trained orthopaedic surgeons reviewed 27 MRIs with varying degrees of rotator cuff pathology
    • Interobserver agreement determined by kappa analysis
slide22

Interobserver agreement studies

  • Interobserver agreement in the classification of rotator cuff tears using magnetic resonance imaging
  • Assessed MRIs for:
    • the ability to detect FT vs. PT tears,
    • acromion morphology,
    • AC joint spurs or signal changes,
    • individual muscle fatty infiltration and atrophy,
    • biceps pathology,
    • size and grade partial thickness tears,
    • acromiohumeral distance,
    • number of tendons involved,
    • amount of retraction for full-thickness tears, and
    • size of full thickness tears
slide23

Interobserver agreement studies

  • Interobserver agreement in the classification of rotator cuff tears using magnetic resonance imaging
  • Highest when distinguishing full-thickness from partial-thickness tears (0.95, K=0.77)
  • Moderate when identifying the number of tendons involved (0.95, K=0.55)
slide25

Additional Manuscripts

  • Indications for Repair of Full-thickness Rotator Cuff
  • Tears (Review)
  • Wolf BR, Dunn WR, Wright R. AJSM June 2007; 35(6): 1007-16.
  • Rotator Cuff Repair Rehabilitation: A Level I and Level II Systematic Review
  • Baumgarten KM, Vidal AF, Wright RW. Submitted to AJSM July 2007
  • 3. Features of Rehabilitation for Rotator Cuff Disease, A Systematic Review
  • Kuhn JE in preparation
slide27

Prospective Cohort Study

Features to predict success with nonoperative treatment for full thickness rotator cuff tears.

  • Specific Aims
    • Study the effect of historical information on predicting success (determined by pain relief & patient satisfaction) of nonoperative treatment using an EBM based PT program
    • Study the effect of physical exam findings on predicting success of nonoperative treatment using an EBM based PT program
    • Study the effect of the severity of the rotator cuff pathology (using standardized MRI protocols) on predicting success of nonoperative treatment using an EBM based PT program.
slide28

Prospective Cohort Study

  • Inclusion Criteria:
    • All patients (18-100 yrs. of age)
    • MRI documented full-thickness (FT) rotator cuff tear
  • Exclusion Criteria
    • Acute rotator cuff tear (RCT)
    • Associated dislocation
    • Associated fracture
    • Systemic Rheumatologic disease
    • Dementia or inability to complete questionnaires
    • Bilateral Cuff tears
slide29

Prospective Cohort Study

  • Enrollment (began Jan. 2007)
    • We are asking sites to keep track of ALL full-thickness rotator cuff tears on a standard enrollment log
        • Total number of FT cuff tears
        • Total number who DO NOT fit I/E criteria
        • Total number who fit I/E criteria and consent
        • Total number who fit I/E criteria and decline to consent
slide30

Prospective Cohort Study

  • Patients presenting WITHOUT an MRI are evaluated in a standard manner to determine if an MRI is indicated to rule out a rotator cuff tear.
  • Patients with an MRI documented FT cuff tear are approached about participation by the attending physician or a member of the research staff.
  • Outcome measures - a self-administered questionnaire, a rehab diary and a modified ASES exam form.
slide31

* A compilation of the SF-12v2, the ASES, the WORC, the Marx

Activity Scale, the SANE, patient expectations and the

Self-Administered Comorbidity Questionnaire.

† Consisted of two questions: Did you go to formal physical therapy?

Did you do a home exercise program?

study to date
Study to Date
  • 1/3 of patients required enrolled
  • 15% drop out rate
  • Early data suggests good response to PT
immediate future of moon shoulder
Immediate Future of MOON Shoulder
  • Continue to Collect Data on Nonoperative Cohort Patients (N=380)
  • Begin NIH Grant for Surgical Treatment Cohort
  • Continue to Explore Agreement Studies and Develop Systematic Reviews on Other Shoulder Topic
a few years from now
A Few Years from Now
  • Randomized Controlled Trials on Interventions to Improve Success with Rotator Cuff Repair
  • Cohort Studies of Other Shoulder Disorders
    • Instability
summary
Summary
  • EBM is the Future of Orthopaedics and Sports Medicine
  • Level-4 Case Series are not worth your time unless the condition is very rare
  • Multicenter Cohort Studies or Trials is the best way to contribute in a clinically meaningful way!
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