Randomized Clinical Trial to Explore the
Efficacy of Concentrated Bone Marrow Aspirate as an Addition to ACL
Revision Surgery
NEW
YORK, May 20, 2024 /PRNewswire/ -- Up to
18% of patients undergoing ACL reconstruction experience graft
failure and require revision surgery, which is known to increase
the risk of developing post-traumatic osteoarthritis (PTOA). A new
trial led by the Center for Regenerative Medicine at Hospital for
Special Surgery (HSS) with a sub-site at Emory
University will investigate whether using concentrated bone
marrow aspirate (cBMA) can help patients to heal more effectively
and prevent PTOA after revision surgery. This translational
research study comes from HSS' new Center for Regenerative
Medicine-based trial to utilize a cell-based therapy.
The 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.
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SOURCE Hospital for Special Surgery