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

Grants and Contracts Details

Description

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.
StatusFinished
Effective start/end date9/30/177/5/22

Funding

  • University of Pittsburgh: $5,019.00

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