news-medical.net
The Marshall University Joan C. Edwards School of Medicine is now accepting applicants for an observational trial focused on fertilized anterior cruciate ligament (ACL) reconstruction.
Unlike traditional ACL repairs, fertilized ACL surgery uses a biologic concentrate of the patient's stem cells, bone marrow and autograft bone along with an internal brace with the goal of stabilizing and expediting the healing process.
Past patients of the fertilized ACL have already shown shorter recovery times with no known additional risks to the patient. With this large-scale study, we hope to determine whether patients, particularly athletes, who have undergone this type of surgery can return to play sooner, which could be a game changer for their sports careers."
Chad D. Lavender, M.D., primary investigator of the study and assistant professor at the Joan C. Edwards School of Medicine
With conventional ACL reconstruction, athletes typically expect a year of recovery before they can play again. However, many of Lavender's patients who have undergone fertilized ACL surgery have cut this recovery time in half. This study includes three tests designed to assess when athletes can return to play post-surgery. Biomechanical testing and/or virtual reality testing will track the individuals' movement to provide objective data on their reaction time, joint angles and acceleration to guide decision making. Force plate testing will look at the musculoskeletal system to see how the participants handle jumping and balance. Inertial measurement unit (IMU) testing will measure movement and focus on how the muscles react.
Patient-reported outcomes will also be measured before surgery, and at 6 weeks, 3 months, 4.5 months, 6 months, 9 months, one year and two years, post-surgery. At 6 months, all participants will undergo magnetic resonance imaging (MRI) of the injured knee to investigate bone socket size. At two years, patients will be asked whether their ACL has re-ruptured.
As founder of the fertilized ACL, Lavender has completed hundreds of procedures on patients from 27 states and internationally. Timothy E. Hewett, Ph.D., professor at the school of medicine, will lead the biomechanical testing and evaluation.
Marshall is currently accepting up to 450 patients for the trial, with approximately 125-150 patients in the FACL group. All patients must be between the ages of 14 and 26. Patients who have undergone previous ACL reconstructive surgery or with multi-ligament surgery are not eligible. Surgeries will only be performed at Cabell Huntington Hospital, a member of Marshall Health Network.
Participants will attend regularly scheduled study visits with Marshall Health physicians for ongoing assessment. Any additional screenings used solely for the study will be at no cost to the patient. To schedule a consultation or for more information about the clinical trial, please call Marshall Orthopaedics at 304.691.6710 or visit marshallhealth.org/research.
Marshall is the only center in the country performing this type of clinical trial. Arthrex provided partial funding of this study.