Treatment for early-stage osteonecrosis using bone marrow aspirate

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of autologous bone marrow aspirate concentrate (BMAC) combined with core decompression in treating early-stage osteonecrosis of the femoral head. It aims to compare clinical and radiological outcomes between patients receiving BMAC and those undergoing core decompression alone. The study will assess the progression of osteonecrosis and the time taken for any radiological changes to occur. Participants will include individuals diagnosed with non-traumatic osteonecrosis at stages 1 or 2, with a focus on preserving joint function and delaying the need for joint replacement.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Southern California
  Los Angeles, California, United States Recruiting
• Stanford University
  Stanford, California, United States Recruiting
• Sinai Hospital of Baltimore
  Baltimore, Maryland, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Lynne C Jones, PhD — Johns Hopkins University
• Study coordinator: Lynne C Jones, PhD
• Email: ljones3@jhmi.edu
• Phone: (410) 550-4001

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.