Timing of Surgery and Rehabilitation to Optimize Outcome for Patients with Multiple Ligament Knee Injuries: A Multicenter Clinical Trial
Abstract
Multiple ligament knee injuries (MLKIs) are serious injuries to the knee that involve a complete tear of two or more ligaments (tissues that connects bone to bone). These injuries are most common after trauma, such as a motor vehicle accident or as a result of a sports injury. Sometimes these injuries are associated with other injuries, such as a fracture or injury to the cartilage, tendons, nerves, and blood vessels that cross the knee that can complicate treatment and lead to a poorer outcome. There is evidence to indicate that non-surgical treatment of a MLKI results in poor outcomes; however, there is no agreement on the best surgical method for treatment of these injuries. There is weak research evidence that surgery soon after injury leads to better results than if surgery is delayed; however, early surgery is associated with an increased risk of a stiff knee, which can cause pain, limited function, and an increased risk of arthritis in the long term. Regardless of the type of treatment, MLKIs often result in persistent pain, stiffness, and limited ability to perform demanding activities such as those associated with military training, heavy physical labor, and sports. A large proportion of military personnel who suffer a MLKI experience ongoing problems with the knee that prevent return to active duty. In one study of military personnel with a MLKI, 46% were determined to be unfit to return to active military duty and most had "some limitations" with daily activities and were only able to perform sports at "half speed." To improve the treatment of MLKIs, we plan to do a study at multiple locations to determine if the timing of surgery and rehabilitation after surgery will lead to improved outcome and return to activity for military personnel and civilians. Individuals participating in this study will be randomly assigned (like the flip of a coin) to either early surgery (within 4 weeks of injury) or delayed surgery and either early (starting within the first week after surgery) or delayed (starting 4 weeks after surgery) rehabilitation. We believe that earlier surgical treatment will result in better outcomes. However, because surgery soon after injury is also associated with a stiff knee, we believe that the best outcome will be achieved when early surgery is combined with early initiation of rehabilitation after surgery. Because the number of MLKIs is relatively small compared to other types of knee injuries, we will need to recruit patients from many sites across the United States and Canada, including military treatment sites, to complete this study. Substantial planning of a study involving multiple sites is required. Therefore, the overarching objectives of this planning grant are to: (1) create a network of researchers at multiple sites that are necessary for successful completion of the study; (2) finalize the design of the research study; (3) decide on the surgical methods and rehabilitation procedures that will be performed; (4) determine the number of patients that are needed for the study and the best way to analyze the results; (5) develop plans to ensure safety of the patients and high quality research data; (6) establish an organizational structure to oversee successful completion of the study; and (7) finalize plans for beginning the study. We expect that these planning activities will require 12 months to complete. The results of this study will provide information on the best way to treat a MLKI in military personnel. We expect that the results of the study will demonstrate that early surgery combined with early post-operative rehabilitation will lead to the best outcomes including an earlier and more complete return to duty/work and sports. In demonstrating the benefits of early surgery and rehabilitation, we will challenge the belief that surgery must be delayed to prevent a stiff knee and that rehabilitation must be delayed to prevent disruption of the repaired tissues. By
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Apr 04, 2016
- Source ID
- W81XWH1510655
Entities
People
- James Irrgang
Organizations
- United States Army
- University of Pittsburgh