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John E. Kuhn, MD Tara T. Holmes, PA-C, MPH Slide 2 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. Slide 3 Outcomes Research Slide 4 MOON Shoulder Ultimate Goal: Study Features that Influence Success of Rotator Cuff Repair Slide 5 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 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 MOON Shoulder Consortium: 9 Sites - 17 Surgeons Slide 6 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 Participating Sites: 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 This research would not be possible without our tremendous support staff! Slide 7 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 Vanderbilt Sports Medicine (Coordinating Center) Additional Research Staff Angela Combs, RN Angela Keen Sarah Editorial Assistance Lynn Sykes Cain Slide 8 NIH 5K23AR052392-02 (Dunn) Clinical Scholars in Epidemiology (Dunn) Features to Predict Success with Non- operative Treatment of Patients with Full- thickness Rotator Cuff Tears (Kuhn) Slide 9 Slide 10 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 Slide 11 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 Slide 12 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 Slide 13 Phase III Randomized Trials Slide 14 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 Slide 15 Consensus No Data in Literature The MOON Shoulder consortium met 7 times (5/04 10/06) with the following goals - 1.Develop standardized criteria for ordering an MRI 2.Develop a consensus on the standard x-ray and MRI imaging techniques 3.Select and develop outcomes instruments Slide 16 Development of Data Collection Forms and Database Patient FormPhysical Exam Form Surgical Data Collection Form Slide 17 Systematic Reviews Nonoperative Physical Therapy Program Surgical Indications in Treatment of Rotator Cuff Disease Postoperative Care Cryotherapy Physical Therapy CPM Slide 18 Original Research Agreement Study on Describing MRI Findings Agreement Study on Describing Intraarticular Pathology Study on Nonoperative Treatment for Common Surgical Indications Slide 19 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) Slide 20 Classification of Video Cuff Disease Inter-observer agreement was high when distinguishing between full thickness and partial thickness tears (0.95, =0.85). The investigators agreed on the side (articular vs. bursal) of involvement for partial thickness tears (observed agreement 0.92, =0.85), but could not agree when classifying the depth of the partial thickness tear (observed agreement 0.49, =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, =0.54). Slide 21 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 Slide 22 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 2.Interobserver agreement in the classification of rotator cuff tears using magnetic resonance imaging Interobserver agreement studies Slide 23 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) Interobserver agreement studies Slide 24 Variable Observed Agreement (percentage) Kapp a Teres minor quantity0.90 Full thickness vs. Partial Thickness0.890.77 AC joint signal change (increased)0.780.33 Subscapularis quantity0.780.04 Number of tendons involved0.720.55 Side of partial thickness tear0.720.44 Infraspinatus quantity0.720.22 Biceps tear0.680.19 AC joint spur0.660.32 Degree of retraction0.630.44 Biceps signal change(increased)0.60.2 Supraspinatus quantity0.590.25 Acromiohumeral distance0.520.26 Acromial morphology(sagital)0.50.16 Partial thickness tear grade0.46-0.11 Acromial morphology(coronal)0.430.06 Size of tear (sagital)0.420.26 Size of tear (coronal)0.420.24 Muscle quality(Goutallier)0.360.1 Slide 25 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 Slide 26 Slide 27 Features to predict success with nonoperative treatment for full thickness rotator cuff tears. Prospective Cohort Study 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. Slide 28 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 Slide 29 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 Slide 30 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. Slide 31 Outcome MeasureTime Point Initial6 wk12 wk2 year5 year10 year Self-administered questionnaire*XXXXXX Rehab Diary XX Physician Exam form (modified ASES)XXX * 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? Slide 32 Study to Date 1/3 of patients required enrolled 15% drop out rate Early data suggests good response to PT Slide 33 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 Slide 34 A Few Years from Now Randomized Controlled Trials on Interventions to Improve Success with Rotator Cuff Repair Cohort Studies of Other Shoulder Disorders Instability Slide 35 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! Slide 36 Thanks!