Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis
This study is investigating a treatment for early-stage osteonecrosis of the femoral head (ONFH), a condition where bone cells in the hip die, leading to pain and potential joint collapse. Researchers are comparing two procedures: standard core decompression (drilling into the affected bone) versus core decompression combined with autologous bone marrow aspirate concentrate. The bone marrow aspirate concentrate, taken from your own body, contains cells that may help bone and blood vessels grow. You may be able to join if you are 18-90 years old, have non-traumatic ONFH in stages 1 or 2, and have no subchondral fracture. The study will look at whether the ONFH progresses, changes in your pain, and how long your hip joint remains healthy, over a period of up to 24 months. The current status of this study is unclear.
- Study design
- This interventional study aims to enroll 192 participants to compare two treatment procedures for osteonecrosis of the femoral head.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 24 months to assess radiological progression, pain levels, and time to femoral head failure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis
At a glance
Conditions
NCT06123481
Where you'd take part
This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cleveland Clinic
Cleveland, Ohiostudy coordinator listed
Recruiting
Johns Hopkins University
Baltimore, Marylandstudy coordinator listed
Recruiting
Mayo Clinic
Rochester, Minnesotastudy coordinator listed
Recruiting
NYU Langone Health Orthopedic Hospital
New York, New Yorkstudy coordinator listed
Recruiting
Sinai Hospital of Baltimore
Baltimore, Marylandstudy coordinator listed
Recruiting
Stanford University
Stanford, Californiastudy coordinator listed
Recruiting
University of Minnesota
Minneapolis, Minnesotastudy coordinator listed
Recruiting
University of Pennsylvania
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Lynne C Jones, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
- Michael A Mont, MD · PRINCIPAL_INVESTIGATOR · Sinai Hospital of Baltimore / LifeBridge Health
- Stuart B Goodman, MD, PhD · PRINCIPAL_INVESTIGATOR · Stanford University
Who to contact
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Inclusion
Exclusion
What this trial measures
- Radiological progression of osteonecrosis of the femoral head (ONFH) to ARCO Stage III or IVUp to 24 months
The 2019 ARCO Staging System encompasses four stages. ARCO Stage I is the earliest stage of osteonecrosis and is characterized by a normal x-ray and an abnormal MRI. ARCO Stage IV is the most advanced stage of osteonecrosis and is characterized by findings of osteoarthritis on x-ray.
- Change in Pain using the Pain VAS scaleUp to 24 months
This is assessed using the pain Visual Analogue Scale (VAS). The participant marks an X on a 10cm scale denoting the level of pain that they are experiencing. VAS measures pain intensity on a scale of 0 (no pain) to 10 (worst pain).
- Time to failure of femoral headUp to 24 months
Time is measured in months following the intervention (core decompression or core decompression with cells). Failure is defined as radiological progression to ARCO Stage III or IV or unremitting pain requiring surgical intervention.