Condition: Osteonecrosis of the Femoral Head · Avascular Necrosis of the Femoral Head · Sponsor: Johns Hopkins University
Osteonecrosis of the femoral head (ONFH) is a debilitating musculoskeletal disease that is characterized by localized death of bone cells and associated cellular elements within the subchondral bone. If it progresses, it results in the collapse of the femoral head (ball part of the hip) giving rise to secondary arthritis. This condition is associated with marked pain and loss of function, often necessitating a joint replacement. Due to the relatively young age of onset of ONFH (often in 20s and 30s), there is great interest in utilizing joint-preserving procedures prior to the need for joint replacement. Joint-preserving procedures include core decompression (CD) with and without bone grafts or cells, vascularized and non-vascularized bone grafting, as well as osteotomies. Inconsistent results for each of these procedures have been reported and there are no Clinical Practice Guidelines or medical community consensus opinions regarding the treatment of early-stage ONFH. The hypothesis to be tested is "Participants who have early-stage ONFH undergoing CD augmented with autogenous bone marrow aspirate concentrate will have better clinical and radiological outcomes than CD alone." This multi-center randomized controlled trial for early-stage ONFH is prospective and controlled for participant stage (only early-stage pre-collapse individuals) and surgical technique. Participants will be evaluated as per routine surgical follow-up, and at 6 months (telemedicine), 1- and 2- years usi…
This description comes directly from the study's public registry record.
Lynne C Jones, PhD · (410) 550-4001 · ljones3@jhmi.edu
Stuart Goodman, MD, PhD · 650-721-7662 · goodbone@stanford.edu
Always discuss trial participation with your own doctor first.
| University of Southern California | Los Angeles, California, United States | Recruiting |
| Stanford University | Stanford, California, United States | Recruiting |
| Sinai Hospital of Baltimore | Baltimore, Maryland, United States | Recruiting |
| Johns Hopkins University | Baltimore, Maryland, United States | Recruiting |
| University of Minnesota | Minneapolis, Minnesota, United States | Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States | Recruiting |
| NYU Langone Health Orthopedic Hospital | New York, New York, United States | Recruiting |
| Cleveland Clinic | Cleveland, Ohio, United States | Recruiting |
| University of Pennsylvania | Philadelphia, Pennsylvania, United States | Recruiting |
| University of Virginia | Charlottesville, Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06123481