Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis
Public ClinicalTrials.gov record NCT06123481. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Autologous Bone Marrow Aspirate Concentrate for the Treatment of Osteonecrosis of the Femoral Head
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06123481
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 192 participants
Conditions and interventions
Interventions
- Core Decompression Procedure
- Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate Procedure
Procedure
Eligibility (public fields only)
- Age range
- 18 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 1, 2025 (Actual)
- Primary completion
- Mar 31, 2029 (Estimated)
- Completion
- Jul 31, 2029 (Estimated)
- Last update posted
- Sep 17, 2026
2025 – 2029
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | Recruiting |
| Stanford University | Stanford | California | 94063 | Recruiting |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | Recruiting |
| Johns Hopkins University | Baltimore | Maryland | 21224 | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | 55455 | Recruiting |
| Mayo Clinic | Rochester | Minnesota | 55905 | Recruiting |
| NYU Langone Health Orthopedic Hospital | New York | New York | 11016 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 441195 | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting |
| University of Virginia | Charlottesville | Virginia | 22903 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06123481, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 17, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06123481 live on ClinicalTrials.gov.