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Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis
NCT06123481 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Core Decompression
- PROCEDURE Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate
Study Locations (10)
California
- University of Southern California — Los Angeles
- Stanford University — Stanford
Maryland
- Sinai Hospital of Baltimore — Baltimore
- Johns Hopkins University — Baltimore
Minnesota
- University of Minnesota — Minneapolis
- Mayo Clinic — Rochester
New York
- NYU Langone Health Orthopedic Hospital — New York
Ohio
- Cleveland Clinic — Cleveland
Pennsylvania
- University of Pennsylvania — Philadelphia
Virginia
- University of Virginia — Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2025-04-01 |
| Est. Completion | 2029-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06123481
The ClinicalTrials.gov registry entry for NCT06123481 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 192 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,517 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Avascular Necrosis of the Femoral Head appearing as the primary indexed condition, and to 2 interventions — of which Core Decompression is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06123481 reports 10 study locations spanning 7 distinct geographic areas — top geographies include California, Maryland, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06123481 about?
NCT06123481 is a clinical study titled "Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis". 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 ...
What is the current status of trial NCT06123481?
This trial is currently recruiting. It is a NA study. The enrollment target is 192 participants. The study started on 2025-04-01. Estimated completion is 2029-07-31.
What conditions does trial NCT06123481 study?
This clinical trial studies the following conditions: Avascular Necrosis of the Femoral Head, Osteonecrosis of the Femoral Head. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06123481?
The interventions under investigation include: Core Decompression (PROCEDURE), Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06123481?
This trial is sponsored by Johns Hopkins University, which has 1,517 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06123481 being conducted?
This trial has 10 study locations across California, Maryland, Minnesota, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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