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Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis

RecruitingNAAges 18 Years - 90 YearsAllJohns Hopkins University
NCT06123481 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 o

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📋 Eligibility rules (as published)
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
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What it tests

  • Core Decompression
  • Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate
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Where

10 sites
University of Southern California
Los Angeles, United States
Stanford University
Stanford, United States
Sinai Hospital of Baltimore
Baltimore, United States
Johns Hopkins University
Baltimore, United States
University of Minnesota
Minneapolis, United States
Mayo Clinic
Rochester, United States
NYU Langone Health Orthopedic Hospital
New York, United States
Cleveland Clinic
Cleveland, United States

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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