Annual Start-Up: Surgical Timing and Rehabilitation (STaR) for Multiple Ligament Knee Injuries (MLKs): A Multicenter Integrated Clinical Trial

Scope of Work for Clinical Trial Development Award Timing of Surgery and Rehabilitation to Optimize Outcome for Patients with Multiple Ligament Knee Injuries: A Multi-Center Clinical Trial The tasks and activities associated with the scope of work to be completed by [insert site/entity name here] as part of participation in the Integrated Clinical Trial Award for a multicenter clinical trial to investigate the effects of timing of surgery and post-operative rehabilitation to optimize return to duty/work and sports and patient-reported physical function for military personnel and civilians with a multiple ligament knee injury include: 1. Actively participating in the planning and conduct of the multicenter clinical trial; 2. Obtaining local IRB and HRPO approval for the study within 3 months of the date of the award; 3. Timely approval and execution of a subcontract, data use agreement and any other agreements that are necessary to conduct that study at [insert site/entity name here]; 4. Participating in site initiation visit as well as annual study monitoring visits; 5. Participating in training activities to ensure that all research personnel are appropriately trained in study procedures; 6. Recruiting, obtaining informed consent and randomizing a minimum of 40 individuals with a multiple ligament knee injury over a two year period. This includes approximately 20 subjects for Specific Aim 1 that are randomized to early vs. delayed surgery and early vs. delayed post-operative rehabilitation and 20 subjects for Specific Aim 2 that are randomized only to early vs. delayed post-operative rehabilitation; 7. Completing baseline data collection that includes the subject’s demographic information, pre-injury activity and patient-reported physical function, findings of the physical examination and imaging; 8. Completing case report forms that document the examination under anesthesia and diagnostic arthroscopy, injury pattern, associated injuries and surgical procedures; 9. Completing case report forms that summarize clinical follow-up of the subject at approximately 1, 3, 6 and 9 to 12 months after surgery including information related to the subject’s recovery, complications/adverse events, post-operative physical therapy and return to activity; 10. Performing study interventions as assigned (early vs. delayed surgery and early vs. delayed rehabilitation) as standard of care; 11. Interacting with the physical therapy provider to ensure that the post-operative rehabilitation is carried out as randomized and to ensure completion of the physical therapy case report forms at 1, 3 and 6 months; 12. Participating in Annual Investigators’ Meeting and regular investigators’ conference calls; 13. Participating in the governance of study including participation on assigned committees and; 14. Contributing to the interpretation and dissemination of the study results.