Actively Recruiting
Autologous Bone Marrow Aspirate Concentrate for the Treatment of Osteonecrosis of the Femoral Head
Led by Johns Hopkins University · Updated on 2025-11-26
192
Participants Needed
10
Research Sites
17 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Osteonecrosis of the femoral head (ONFH) is a painful condition where bone cells in the hip die, leading to the collapse of the femoral head and potentially arthritis. This condition often affects younger adults in their 20s and 30s, and joint-preserving treatments are important to delay or avoid joint replacement surgery. This study aims to compare core decompression surgery alone with core decompression combined with autologous bone marrow aspirate concentrate (BMAC) to see which method leads to better clinical and imaging results in early-stage ONFH. Participants will be randomly assigned to one of two groups: one receiving core decompression alone with a sham bone marrow aspiration, and the other receiving core decompression plus concentrated bone marrow aspirate injected into the hip bone. The bone marrow sample will be analyzed to understand the cells and biological pathways involved. Both procedures follow a standardized protocol to ensure consistency across participants. Throughout the study, participants will be monitored with routine surgical follow-ups and assessments including radiographs, MRIs, and questionnaires at multiple time points up to 24 months. Key outcomes measured include radiological progression of ONFH, pain levels using the Pain Visual Analog Scale, and time until treatment failure. Additional assessments of symptoms, function, quality of life, and mental and physical health will be collected at baseline, 6, 12, and 24 months. This study will help understand which treatment better preserves the hip joint in early ONFH cases.
CONDITIONS
Brief Title
Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with non-traumatic osteonecrosis of the femoral head
- Only those with Stage 1 or 2 osteonecrosis as assessed by the 2019 ARCO Staging System
- No evidence of subchondral fracture
- All sizes of osteonecrotic lesions
- Inclusion of all major risk factors except those listed in exclusion criteria
- Participants with femoral head osteonecrosis without identified risk factors
- Participants of all ethnicities and races
- Able and willing to participate and return for postoperative visits
You will not qualify if you...
- Participants with sickle cell disease
- Participants with major trauma
- Participants with post-irradiation osteonecrosis
- Participants with Gaucher disease
- Participants with juvenile forms of osteonecrosis (Legg-Calve-Perthes Disease or spontaneous hip osteonecrosis)
- Pregnant or breastfeeding individuals
- Vulnerable populations such as prisoners and institutionalized individuals
- Unable to undergo MRI
- Evidence of subchondral fracture
- Prior history of hip surgery more extensive than hip arthroscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Single procedure with follow-up assessments up to 24 months
Participants receive either core decompression with autologous bone marrow aspirate concentrate or core decompression alone with a sham bone marrow aspiration.
Pre-operative baseline visit; post-operative visits at 6, 12, and 24 months
Duration - Up to 24 months post-treatment
Participants are monitored with clinical assessments, radiographs, and MRIs to evaluate progression of osteonecrosis and pain up to 24 months after treatment.
Post-operative visits at 6, 12, and 24 months including clinical research forms, radiographs, and MRIs
Trial Site Locations
Total: 10 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
Stanford University
Stanford, California, United States, 94063
Actively Recruiting
3
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
4
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Actively Recruiting
5
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
6
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
NYU Langone Health Orthopedic Hospital
New York, New York, United States, 11016
Actively Recruiting
8
Cleveland Clinic
Cleveland, Ohio, United States, 441195
Actively Recruiting
9
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
L
Lynne C Jones, PhD
S
Stuart Goodman, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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