Surgical Timing and Rehabilitation (STaR) for Multiple Ligament Knee Injuries (MLKIs): A Multicenter Integrated Clinical Trial
Abstract
The objective of this project is to conduct two parallel, multicenter randomized clinical trials to determine how the timing of surgery (early vs. delayed) and rehabilitation (early vs. delayed) affects time to return to military duty, work, and sports and knee-related patient-reported physical function for 690 military personnel and civilians between the ages of 16 and 55 with a multiple ligament knee injury. To date, we have received IRB approval for 14 sites and approval by HRPO for 5 sites. Additionally, 4 sites are currently under review by HRPO. Research activities over the past year have included finalizing the detailed study protocol, approval of the DSMB to start recruitment, creation and testing of the central study database, bi-weekly training sessions for research coordinators, and monthly investigators calls. In the past 2 months, the coordinating center at Pitt has conducted site initiation visits at 5 sites in preparation for HRPO approval. At this time, only the coordinating center at the University of Pittsburgh has been approved for recruitment and has recruited and randomized 3 participants since July 1, 2018. We anticipate recruitment will start at 4 sites in November 2018 and all sites will be actively recruiting by the end of February 2019.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2018
- Accession Number
- AD1074291
Entities
People
- James J. Irrgang
Organizations
- University of Pittsburgh