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Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis

Sponsor: Johns Hopkins University • ClinicalTrials.gov ID: NCT06123481

Registry updated: 2026-09-17

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Description

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 using radiographs, MRIs, and questionnaires. This project will also explore the scientific basis for success vs. failure in individuals who have osteonecrosis, and have different demographics and bone marrow aspirate cell profiles.

Interventions

Core Decompression (Procedure)
Standard core decompression procedure is performed by drilling into the necrotic bone of the femoral head. A sham bone marrow aspiration involves advancing a needle to the iliac crest (no bone penetration, no bone marrow aspiration) through a small skin incision.
Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate (Procedure)
This involves bone marrow aspiration, concentrating the bone marrow aspirate, and injecting 6 milliliters of bone marrow aspirate concentrate into the necrotic femoral head through an opening created by the core decompression.

Eligibility criteria

Inclusion Criteria * Participants who have non-traumatic osteonecrosis of the femoral head * Only participants who have Stage 1 or 2 osteonecrosis as assessed by the 2019 ARCO Staging System * No evidence of subchondral fracture * All osteonecrotic lesion sizes * All major risk factors (e.g. corticosteroids, alcohol, organ recipient) except for those listed in the exclusion criteria * Participants diagnosed who have femoral head osteonecrosis for which no risk factor has yet to be identified * Participants will include all ethnicities and races * Be able and willing to participate in study and return for postoperative visits Exclusion Criteria * Participants who have: * Sickle Cell disease * Major trauma * Post-irradiation ON * Gaucher Disease * Juvenile form: Legg-Calve-Perthes Disease * Juvenile form: Spontaneous ON of the hip * Pregnant or breastfeeding * Vulnerable population; i.e., prisoners and institutionalized individuals * Participant is unable to undergo an MRI * Participants who have evidence of a subchondral fracture * Prior history of hip surgery, more extensive than hip arthroscopy

Conditions

Osteonecrosis of the Femoral Head Avascular Necrosis of the Femoral Head

Locations

University of Southern California — Los Angeles, California, United States
Stanford University — Stanford, California, United States
Sinai Hospital of Baltimore — Baltimore, Maryland, United States
Johns Hopkins University — Baltimore, Maryland, United States
University of Minnesota — Minneapolis, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States
NYU Langone Health Orthopedic Hospital — New York, New York, United States
Cleveland Clinic — Cleveland, Ohio, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
University of Virginia — Charlottesville, Virginia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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