NCT06123481 Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis
| NCT ID | NCT06123481 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Osteonecrosis of the Femoral Head |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 192 participants in total. It began in 2025-04-01 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Lynne C Jones, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06123481 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Osteonecrosis of the Femoral Head. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06123481 currently recruiting?
Yes, NCT06123481 is actively recruiting participants. Contact the research team at ljones3@jhmi.edu for enrollment information.
Where is the NCT06123481 trial being conducted?
This trial is being conducted at Los Angeles, United States, Stanford, United States, Baltimore, United States, Baltimore, United States and 6 additional locations.
Who is sponsoring the NCT06123481 clinical trial?
NCT06123481 is sponsored by Johns Hopkins University. The principal investigator is Lynne C Jones, PhD at Johns Hopkins University. The trial plans to enroll 192 participants.