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.
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.
Outcomes Research
MOON Shoulder
Ultimate Goal: Study Features that
Influence Success of Rotator Cuff Repair
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
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
This research would not
be possible without our
tremendous support staff!
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
Vanderbilt Sports Medicine (Coordinating Center)
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
Additional Research Staff
Angela Combs, RN
Angela Keen
Sarah
Editorial Assistance
Lynn Sykes Cain
Features to Predict Success with Nonoperative Treatment of Patients with Fullthickness Rotator Cuff Tears (Kuhn)
NIH 5K23AR052392-02 (Dunn)
Clinical Scholars in Epidemiology (Dunn)
Ongoing Development
1. Monthly Conference calls to review/discuss issues
related to current study and to discuss
additional/future studies
2. Group meets in-person three times per year
3. Manual of Operations gets reviewed and updated as
necessary
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
•
•
•
•
•
Prospective Cohort Study
2000 patients
Long F/U with MRI
NIH Funding
Identify Controllable Features that Influence
Failure of Rotator Cuff Repair
Phase III – Randomized Trials
The MOON Shoulder consortium met 7 times (5/04 –
10/06) with the following goals 1. Formulate research questions of interest for the
study of rotator cuff disease
2. Develop standardized criteria for ordering an MRI
3. Develop a consensus on the standard x-ray and MRI
imaging techniques
4. Select and develop outcomes instruments
Consensus
No Data in Literature
The MOON Shoulder consortium met 7 times (5/04 –
10/06) with the following goals 1.
2.
3.
Develop standardized criteria for ordering an MRI
Develop a consensus on the standard x-ray and MRI
imaging techniques
Select and develop outcomes instruments
Development of Data Collection Forms
and Database
Patient Form
Physical Exam Form
Surgical Data Collection Form
Systematic Reviews
• Nonoperative Physical Therapy Program
• Surgical Indications in Treatment of Rotator
Cuff Disease
• Postoperative Care
– Cryotherapy
– Physical Therapy
– CPM
Original Research
• Agreement Study on Describing MRI Findings
• Agreement Study on Describing Intraarticular
Pathology
• Study on Nonoperative Treatment for Common
Surgical Indications
Interobserver agreement studies
1. 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)
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).
Interobserver agreement studies
2. 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
Interobserver agreement studies
2. 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
Interobserver agreement studies
2. 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)
Variable
Teres minor quantity
Observed
Agreement
(percentage)
Kapp
a
0.9
0
Full thickness vs. Partial
Thickness
0.89
0.77
AC joint signal change
(increased)
0.78
0.33
Subscapularis quantity
0.78
0.04
Number of tendons involved
0.72
0.55
Side of partial thickness tear
0.72
0.44
Infraspinatus quantity
0.72
0.22
Biceps tear
0.68
0.19
AC joint spur
0.66
0.32
Degree of retraction
0.63
0.44
0.6
0.2
Supraspinatus quantity
0.59
0.25
Acromiohumeral distance
0.52
0.26
0.5
0.16
Partial thickness tear grade
0.46
-0.11
Acromial morphology(coronal)
0.43
0.06
Size of tear (sagital)
0.42
0.26
Size of tear (coronal)
0.42
0.24
Muscle quality(Goutallier)
0.36
0.1
Biceps signal change(increased)
Acromial morphology(sagital)
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.
2. 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
Prospective Cohort Study
Features to predict success with nonoperative
treatment for full thickness rotator cuff tears.
Specific Aims
1. Study the effect of historical information on predicting success
(determined by pain relief & patient satisfaction) of
nonoperative treatment using an EBM based PT program
2. Study the effect of physical exam findings on predicting success
of nonoperative treatment using an EBM based PT program
3. 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.
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
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
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.
Outcome Measure
Self-administered
questionnaire*
Rehab Diary †
Physician Exam form
(modified ASES)
Time Point
12 wk 2 year 5 year 10 year
Initial
6 wk
X
X
X
X
X
X
X
X
X
X
X
* 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
• 1/3 of patients required enrolled
• 15% drop out rate
• Early data suggests good response to PT
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
• Randomized Controlled Trials on Interventions
to Improve Success with Rotator Cuff Repair
• Cohort Studies of Other Shoulder Disorders
– Instability
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!
Thanks!