Timing of Surgery and Rehabilitation to Optimize Outcome for Patients with Multiple Ligament Knee Injuries: A Multicenter Clinical Trial
Abstract
The overall purpose of this Clinical Trial Development Award (CTDA) was to plan a multicenter randomized clinical trial to investigate the effects of timing of surgery and rehabilitation to optimize clinical outcome and return to duty/activity for military personnel and civilians with amultiple ligament knee injury (MLKI). The objectives for the CTDA were to: 1) further develop the research network to ensure access to an adequate number individuals with a MLKI necessary for successful recruitment of the required number of subjects; 2) finalize the experimental design including issues related to subject eligibility, randomization and outcome measurement; 3) develop clinical protocols for surgery and post-operative rehabilitation; 4) finalize the required sample size and develop the statistical analysis and data management plans; 5) develop a clinical and safety monitoring plan; 6) establish a governance structure to oversee conduct of the study; 7) develop a site monitoring plan that includes guidelines for closing and adding sites; and 8) develop a transition plan to move to implementation of the clinical trial. All tasks for the CTDA were successfully completed resulting in an application that was funded to support the conduct of the trial.
Document Details
- Document Type
- Technical Report
- Publication Date
- Dec 01, 2018
- Accession Number
- AD1072004
Entities
People
- James J. Irrgang
Organizations
- University of Pittsburgh