Surgical Timing and Rehabilitation (STaR) for Multiple Ligament Knee Injuries (MLKIs): A Multicenter Integrated Clinical Trial
Abstract
Background: Combat and sports injuries as well as automobile accidents can result in complex knee injuries involving tears of two or more major ligaments. These are referred to as multiple ligament knee injuries (or knee dislocations). Other structures like nerves, blood vessels, tendons, and bones may also be injured. Because of their severity, knee dislocations are difficult to treat, and problems after surgery, such as poor healing, stiffness or looseness of the knee, persistent pain, and early arthritis, can be quite common. After surgery for knee dislocations, individuals are frequently limited in performing activities related to military training, work, and sports. Return to military duty after knee dislocations has been reported to be as low as 40%. Experts agree that surgery is necessary after knee dislocation, but they do not agree on when to perform surgery or when rehabilitation (rehab) should be started and there exists no good research to answer these questions. Early surgery for knee dislocations may result in better outcomes, but may also be associated with increased joint stiffness. However, delayed surgery may be associated with the knee healing and being too loose. The best evidence for when to start rehabilitation is based on anterior cruciate ligament (ACL) injuries in sports, where early post-op rehab is the standard. However, unlike ACL surgery, which typically replaces the ACL with a tendon graft, surgeons frequently sew torn ligaments back together after knee dislocation. Therefore, rehab typically involves protection of the knee by keeping weight off the leg and only allowing the knee to move a little for 6 weeks, which delays return to activity. Without good evidence for when to do surgery and when to start rehab, a large-scale clinical study is needed to improve the outcomes for these devastating injuries. Objective: The overall purpose of this project is to determine when it is best to do surgery (within 6 weeks of injury or 3 to 4 months after injury) and when to start rehab (immediately or 4 weeks after surgery) for the treatment of knee dislocations or how long it takes to resume pre-injury military duty, work, and sports. Study Design: We will recruit military personnel and civilians between the ages of 14 and 65 with a knee dislocation. We will exclude individuals that have major injury to a blood vessel or other body part that prevents them from having knee surgery or participating in rehab. We will conduct two studies at the same time. Two studies are necessary because there are major questions about when is the best time to do surgery and when to start rehab. We also need to determine when it is best to start rehab when the timing of surgery is predetermined. In the first study, we will randomly assign (like flipping a coin) 392 individuals with a knee dislocation to early (within 6 weeks of injury) or delayed surgery (12 to 16 weeks after injury) and early rehab (no restrictions on weight bearing or range of motion) or delayed rehab (no weight bearing and only limited motion for 4 weeks), resulting in the comparison of four groups: Early Surgery & Early Rehab, Early Surgery & Delayed Rehab, Delayed Surgery & Early Rehab, and Delayed Surgery & Delayed Rehab. In the second study, which is to determine when it is best to start rehab in those that cannot be randomly assigned to knee surgery, 298 individuals with a knee dislocation will be randomly assigned to start early or delayed rehab. Subjects in all studies will report their activity and function via internet surveys for 24 months after surgery. Our main interest is the time it takes to return to pre-injury military duty, work, and sports. We will also look at questionnaires that measure knee health and general health, as well as whether knees are too stiff, too loose, the need for other surgeries, and any poor outcomes that might occur. Military Benefit and Clinical Impact: Knee dislocations dramatica
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1720073
Entities
People
- James Irrgang
Organizations
- United States Army
- University of Pittsburgh