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UrduThe new single-blind, randomized, pilot, clinical trial, part of the Arthritis Foundation 2023 FastOA Interventional Pilot Studies, will harness the expertise of surgeons, radiologists, biostatisticians, and cellular and molecular biologists to determine whether cBMA may prevent the chronic inflammation that can lead to pain and stiffness following surgery, and can also contribute to post-traumatic osteoarthritis. Previous studies have suggested that cBMA injections may improve surgical outcomes, but this approach has not yet been evaluated in rigorous clinical trials in patients undergoing ACL revision surgery.
The cBMA used in these procedures is the patient’s own and is collected from the pelvic bones. The participating patients will be randomized to receive either cBMA injections at the time of revision surgery or standard care.
The goal of the trial is not only to establish whether the addition of cBMA reduces the risk of PTOA, but also to understand the underlying mechanisms of cBMA therapy and to look for biomarkers in the joint microenvironment that might help to refine the approach and further improve outcomes. Given the lack of effective non-surgical interventions for the prevention and treatment of PTOA, this study is expected to provide valuable insights that could guide care in the future.
To determine whether any differences observed between the two arms of the trial are clinically meaningful, the primary measure of the treatment’s success will be the patients’ self-reported pain levels 12 months after surgery. This will be determined by using the Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain. As a secondary measure, the investigators will deploy advanced, quantitative MRI scans to look for changes in the cartilage. “We will leverage clinical outcomes and imaging to evaluate the efficacy of adding cBMA to standard treatment,” said co-primary investigator Miguel Otero, PhD, scientist in the Orthopedic Soft Tissue Research Program, co-director of the Derfner Foundation Precision Medicine Laboratory, and of the HSS Research Institute Histopathology Service.
“Depending on what we learn about whether cBMA reduces the risk of PTOA, the results generated by this study may have the potential to change clinical practice,” added co-primary investigator Scott Rodeo, MD, Vice Chair of Orthopaedic Research, co-director of the Orthopaedic Soft Tissue Research Program, and director of the Center for Regenerative Medicine at HSS.
By analyzing the cellular and molecular make-up of the cBMA as well as synovial fluids collected during and after the ACL revision surgery, the investigators also hope to gain insight into the populations of immune cells present within the joint microenvironment and the link between certain immune components and clinical outcomes. The researchers hypothesize that cBMA’s functionally relevant immune-modulatory and disease-modifying effects depend on the fluid’s cellular and molecular composition. They expect that these biospecimens may yield clues about how to further improve patient outcomes.
The FastOA2023 trial will harness strength of two Arthritis Foundation OACTN Clinical Trial Units that are also participating in the Post-Injury Knee Arthritis Severity Outcomes (PIKASO) Study and will use parallel instruments and dataset management. PIKASO is an ongoing, multicenter, randomized phase II clinical trial examining the use of metformin in patients who are at high-risk for developing PTOA in the knee after ACL reconstruction.
To learn more about the study and when enrollment opens in FastOA2023 visit https://clinicaltrials.gov/study/NCT06311513?locStr=New%20York,%20NY&country=United%20States&state=New%20York&city=New%20York&cond=ACLR&intr=BMAC&rank=1
About HSS
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 14th consecutive year), No. 2 in rheumatology by U.S. News & World Report (2023-2024), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report “Best Children’s Hospitals” list (2023-2024). In a survey of medical professionals in more than 20 countries by Newsweek, HSS is ranked world #1 in orthopedics for a fourth consecutive year (2023). Founded in 1863, the Hospital has the lowest readmission rates in the nation for orthopedics, and among the lowest infection and complication rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center five consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State, as well as in Florida. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. In addition, more than 200 HSS clinical investigators are working to improve patient outcomes through better ways to prevent, diagnose, and treat orthopedic, rheumatic and musculoskeletal diseases. The HSS Innovation Institute works to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 165 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.
