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Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis

Key facts

Who runs it
Johns Hopkins University
Where
Baltimore, Charlottesville, Cleveland, Los Angeles, Minneapolis, New York, Philadelphia, Rochester, and Stanford, United StatesSee the 10 sites
Trial code
Status
Recruiting
People taking part
192 people, planned
Started
1 Apr 2025
Expected to end
31 Jul 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Core Decompression
  • Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate
Record updated
17 September 2026

Who can take part

Age
18 years to 90 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior history of hip surgery, more extensive than hip arthroscopy
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 90 years old?

Where in United States

  • Johns Hopkins UniversityBaltimore, United StatesContact: Lynne C Jones, PhDTaking people
  • Sinai Hospital of BaltimoreBaltimore, United StatesContact: Nathaniel Helwig, MDTaking people
  • University of VirginiaCharlottesville, United StatesContact: Eric McVey, MEd, CCRPTaking people
  • Cleveland ClinicCleveland, United StatesContact: Shujaa Khan, MBBSTaking people
  • University of Southern CaliforniaLos Angeles, United StatesContact: Pui Yuk Yan, CCRP, MSCR, MSLTaking people
  • University of MinnesotaMinneapolis, United StatesContact: Lobsang Palma, MPHTaking people
  • NYU Langone Health Orthopedic HospitalNew York, United StatesContact: Daniel Waren, CCRPTaking people
  • University of PennsylvaniaPhiladelphia, United StatesContact: Helena Moses, BSNTaking people
  • Mayo ClinicRochester, United StatesContact: Erin Hennessey, BATaking people
  • Stanford UniversityStanford, United StatesContact: Angela N Bye, MATaking people

About the trial

What the trial wants to find out

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 or medical community consensus opinions regarding the treatment of early-stage ONFH. The hypothesis to be tested is "Participants who have early-stage ONFH undergoing CD augmented with autogenous bone marrow aspirate concentrate will have better clinical and radiological outcomes than CD alone." This multi-center randomized controlled trial for early-stage ONFH is prospective and controlled for participant stage (only early-stage pre-collapse individuals) and surgical technique. Participants will be evaluated as per routine surgical follow-up, and at 6 months (telemedicine), 1- and 2- years using radiographs, MRIs, and questionnaires. This project will also explore the scientific basis for success vs. failure in individuals who have osteonecrosis, and have different demographics and bone marrow aspirate cell profiles.

The 2 groups in the trial

  • Core decompression (CD)Existing treatment, for comparison

    Core decompression of the femoral head with sham bone marrow aspiration

    Treatment: Core Decompression

  • Bone Marrow Aspirate Concentrate (BMAC)Treatment being tested

    Autologous bone marrow aspiration is concentrated and injected into the necrotic bone of the femoral head through the core decompression opening.

    Treatment: Core Decompression and Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Autologous Bone Marrow Aspirate Concentrate for the Treatment of Osteonecrosis of the Femoral Head
Fit questions
Built from NCT06123481, who can take part
Record updated
17 September 2026