NCT06123481 · Johns Hopkins University
Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis
(BATON)
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
- Stanford, California
- Baltimore, Maryland
- Minneapolis, Minnesota
- Rochester, Minnesota
- New York, New York
- Cleveland, Ohio
- Philadelphia, Pennsylvania
- Charlottesville, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 26, 2025 · Source of record for eligibility and locations