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Weight Bearing Study Dr. Bill Obremskey July 12, 2019

Weight Bearing Study Dr. Bill Obremskey July 12, 2019. A genda. Study Team Introductions Overview of the Study PT Involvement Regulatory Process IRB submission Certification Study Materials Next Steps. Introductions. Protocol Committee and PT Panel. Study Overview.

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Weight Bearing Study Dr. Bill Obremskey July 12, 2019

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  1. Weight Bearing StudyDr. Bill ObremskeyJuly 12, 2019

  2. Agenda • Study Team Introductions • Overview of the Study • PT Involvement • Regulatory Process • IRB submission • Certification • Study Materials • Next Steps

  3. Introductions

  4. Protocol Committee and PT Panel

  5. Study Overview • Multi center randomized controlled trial comparing outcomes following early versus delayed weight bearing for adult patients operatively treated for fractures of the ankle and tibial plateau • 20 METRC centers participating • 15-17 Civilian Centers • 3 Military Treatment Facilities • Aiming to enroll and randomize 526 ankle fractures (263 in each group) and 100 tibial plateau fractures • Enrollment will begin this fall • 24 month enrollment period • 12 month follow-up

  6. Background • The goal of ankle fracture treatment is to return patients to full unrestricted weight bearing, normal gait, full mobility and joint range of motion, and regular activities including work as soon as possible. • The time point at which patients are instructed to weight bear may directly or indirectly influence these goals.

  7. Background • Current clinical practice is to restrict weight bearing for at least 6 weeks following definitive treatment • Driven by safety concerns (e.g. risk of hardware failure) • Risks may be minimized with newer fixation technologies and surgical techniques, providing opportunity to weight bear earlier • There are advantages to early weight bearing • Maintains muscle strength and joint range of motion • Stimulates bone healing • May lead to faster recovery

  8. Background • Prior studies have shown a positive impact of early weight bearing after surgical treatment of an ankle fracture. However: • Testing slightly different protocols • Majority of studies include ankle joint immobilization • Randomized trials to date have been small and lack of standardized control groups, and do not rigorously evaluate compliance with weight bearing protocols • Few studies on early weight bearing in tibial plateau fractures

  9. Primary Aim • To compare clinical outcomes and return to usual major activities in patients randomized to early versus delayed weight bearing (WB). • The rate of complications in the early WB group will be non inferior to that of the delayed WB group at 12 months. Complications include hardware failure, malunion, non-union, loss of reduction, fusion and infection. • Patients in the early WB group will return to work and usual major activities sooner than those in the delayed WB group.

  10. Secondary Aims • To compare measures of function and pain • To compare range of motion (ROM) • To estimate the cost effectiveness of early versus delayed weight bearing

  11. Outcome Measures • Complications associated with the study injury will be documented prospectively. Complications of interest include loss of reduction, hardware failure, infection, non-union, malunion and fusion • Return to work and usual activities • Patient reported function • Physical function (PROMIS) • Pain intensity and pain interference (PROMIS & BPI) • Joint specific function (KOOS, FAOS) • ROM • Cost effectiveness • VR-12 • Readmissions and use of other health services (e.g. PT)

  12. Inclusion Criteria • Adults ages 18-65 inclusive • Surgically treated open or closed fractures of the ankle (OTA Codes 44A,B,C) meeting one of the following criteria: • vertical shear medial malleolous with lateral malleolar fracture • bimalleolar fracture requiring medial and lateral fixation • trimalleolar fracture with or without posterior malleolar fixation • Operatively treated isolated lower extremity lateral tibial plateau fracture (AO/OTA 41B, Schatzker Type 1or 4) without joint impaction.

  13. Key Exclusion Criteria • Contraindications to immediate WB including: • Contralateral fractures and severe soft tissue injury • Severe osteoporosis where fixation is marginally stable, • Ipsilateral fractures such as a calcaneus fracture (fractures that would not affect WB status may be included e.g. proximal femur, femoral shaft or tibia shaft fractures) • Any upper limb injury that would limit weight bearing (e.g. surgical neck fracture of proximal humerus) • Injuries to other body systems such as spinal cord injury; severe TBI; major abdominal or chest injury • Third degree burns on >10% total surface area affecting the study limb. • Pre-injury limitation to ROM of ipsilateral hip, knee or ankle. • Morbidly obesity (BMI >=40) • Syndesmotic injuries/fixation

  14. Treatment Groups

  15. Weight Bearing Guidelines for the Study Early Weight Bearing (EWB) Instructions: Weight bearing as tolerated after 2-week visit Delayed Weight Bearing (DWB) Instructions: Toe-touch for balance only and no more than 10% for the first six weeks EWB Exercises Weight bearing instructions for ‘as tolerated’ PT to discuss how to progress during weekly calls Two-way text reminders EWB Exercises Add more challenging exercises (e.g. standing hip adduction) Continue WBexercises without the boot Everyone non-weight bearing 6-Week Visit Study Evaluations 3-Month Visit Study Evaluations 2-Week Visit Randomized & Study Evaluations Provided with guidance to not weight bear on injured leg Enrollment Definitive Fixation In Hospital DWB Exercises Weight bearing instructions as for balance and no more than 10% Standardized exercises PTs to call weekly to ask about recovery Two-way text reminders DWB Begin weight bearing exercises Add more challenging exercises at Week 8/9

  16. Compliance & Treatment Fidelity • Participants will be sent weekly reminders and 2-way texts tailored to the WB group they are assigned. • A subset of participants (at 3-4 centers) will be asked to wear insoles with WB sensors to monitor treatment fidelity during first 4 weeks. • Conducting a pilot at VMC and JHU to work out the logistics and data applications

  17. PT Involvement • Each site has identified a physical therapist to work on this study. • Local site PTs will: • Train Coordinators to measure ankle and knee ROM during study visits • Provide support and guidance Coordinators delivering WB instructions to participants • Monitoring patient progression through home based exercise program and address questions and concerns about weight bearing during weekly calls

  18. Regulatory Process

  19. Submit master protocol to local IRB • Includes all required DoD and HIPPA language • Submit to local IRB by 7/30/19 and let Liz know once it’s been submitted. • Submit IRB approved documents (Local IRB application, protocol, consent form, HIPAA form) to DoD HRPO for review and approval • Must include PI Biosketch or CV, Roles & Responsibilities Table, and Human Subjects Training Certificates for PI and AI’s, (see DoD Email Templates and Checklists posted to the website) • Submit to DoD within 7 days of receiving local IRB approval and remember to copy Liz on your submission emails IRBProcedures

  20. 9. WILL YOU SHARE MY INFORMATION WITH OTHERS? • We will use your information only for the purposes of this study. The data from the study may be published. However, you will not be identified by name. People designated from the institutions where the study is being conducted will be allowed to inspect sections of your medical and research records related to the study. Everyone using study information will work to keep your personal information confidential. Your personal information will not be given out unless required by law. • The Department of Defense is providing funding to sponsor this study. Representatives from the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP) Human Research Protections Office (HRPO) may have access to research records in their role to protect human subjects engaged in research. Consent Form: Required DoD Language Please note that DoD requires the following statement to appear in your consent forms:

  21. Documents for Submission

  22. JHSPH IRB recommend we remove any exclusion around language • New guidance seeks to broaden eligibility criteria for improving enrollment of underrepresented populations • MCC will work with sites who have resources (translators/bilingual staff) to enroll non-English speakers New FDA Guidelines, re: Inclusion

  23. Reporting Requirements

  24. This study will utilize delayed certification • After full review of first three enrolled, full certification letter issued • Use MCC Certification email templates and checklist as a guide for submitting materials for this process • Submit electronically to Liz within 7 days of DoD submission • Clinical Site Certification Form • Biosketch or CVs (if not previously submitted) • Good Clinical Practice Training Certificates (for PI and RC, if not previously submitted or expired) • Must receive approval from MCC to start enrollment Certification Procedures

  25. All study materials will be posted on the METRC website • CRFs & supplemental instructions will be provided for sites to print from • iPad/tablet for data collection • Weight Bearing Instructions and training materials • Boot stickers and texting services • Study Brochure Study Materials & Resources

  26. Each site will get a subcontract that includes small amount of effort for the site PI in each year, and effort for a Research Coordinator in year 1 to initiate the study. • Subsequent payment will be made per patient enrolled • $2,170 per patient (includes $150 honoraria) • Payments will be pro-rated for completed study visits • $7,850 is budgeted to support the site PT up to 180 hours of research related activities over the course of the study (includes calls with participants and providing on-going support and training to Research Coordinators) Contracts and Invoicing

  27. In August/September, METRC will host a study training for physical therapists and research coordinators, focusing on: • Delivering WB instructions • Medical record review • Collaboration between PTs and RCs • Walk through of baseline visit • All sites should attend/document review of WebEx Central Training

  28. July • Subcontracts have been sent from JHU • August-September • Submit for regulatory review • Local IRB • HRPO • MCC Certification • August - September • Centralized training and verification • REDCap Piloting • Enrollment Next Steps

  29. Questions? • Thanks!

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