Status:
RECRUITING
Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Osteonecrosis of the Femoral Head
Avascular Necrosis of the Femoral Head
Eligibility:
All Genders
18-90 years
Phase:
NA
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. ...
Detailed Description
Rationale. It is estimated that there are 10,000 to 20,000 new cases of osteonecrosis of the femoral head diagnosed each year in the United States. Several approaches to treatment have been undertaken...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2029
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06123481
Start Date
April 1 2025
End Date
July 31 2029
Last Update
November 26 2025
Active Locations (10)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
Stanford University
Stanford, California, United States, 94063
3
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
4
Johns Hopkins University
Baltimore, Maryland, United States, 21224