Recruiting

Autologous Bone Marrow AspirateAutologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis

Sponsor:

Johns Hopkins University

Code:

NCT06123481

Conditions

Osteonecrosis of the Femoral Head

Avascular Necrosis of the Femoral Head

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Core Decompression

Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate

Study Details

Brief summary:

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.

Conditions

Osteonecrosis of the Femoral Head

Avascular Necrosis of the Femoral Head

Study ID

NCT06123481

Start date

Apr 1, 2025

Status verified date

Nov, 2025

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

192 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Core decompression (CD)

Core decompression of the femoral head with sham bone marrow aspiration

experimental: Bone Marrow Aspirate Concentrate (BMAC)

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

Interventions

Core Decompression

Standard core decompression procedure is performed by drilling into the necrotic bone of the femoral head. A sham bone marrow aspiration involves advancing a needle to the iliac crest (no bone penetration, no bone marrow aspiration) through a small skin incision.

Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate

This involves bone marrow aspiration, concentrating the bone marrow aspirate, and injecting 6 milliliters of bone marrow aspirate concentrate into the necrotic femoral head through an opening created by the core decompression.

Primary outcome measure

Radiological progression of osteonecrosis of the femoral head (ONFH) to ARCO Stage III or IV [ Time Frame: Up to 24 months ]
Change in Pain using the Pain VAS scale [ Time Frame: Up to 24 months ]
Time to failure of femoral head [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Lynne C Jones, PhD

(410) 550-4001 ljones3@jhmi.edu

Stuart Goodman, MD, PhD

650-721-7662 goodbone@stanford.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Pui Yuk Yan, CCRP, MSCR, MSL

714-470-0614 puiyan@med.usc.edu

Megan Walsh, MBA

617-581-7337 megan.walsh@med.usc.edu

Principal Investigator:

Jay R Lieberman, MD

Stanford University

Recruiting

Stanford, California, United States, 94063

Contacts

Angela N Bye, MA

650-721-7632 abye@stanford.edu

Stuart B Goodman, MD, PhD

Goodbone@stanford.edu

Principal Investigator:

Stuart B Goodman, MD, PhD

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Nathaniel Helwig, MD

410-601-8434 nhelwig@lifebridgehealth.org

Taj-Jamal Andrews, MD

410-601-9592 tandrews@lifebridgehealth.org

Principal Investigator:

Michael A Mont, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Anirudh Buddhiraju, MD

551-271-6992 abuddhi1@jhmi.edu

Lynne C Jones, PhD

410-550-4001 ljones3@jhmi.edu

Principal Investigator:

H. Paul S Khanuja, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Lobsang Palma, MPH

612-626-1652 Lobsa006@umn.edu

Annie Paulison, BA, BS

612-625-3526 pauli098@umn.edu

Principal Investigator:

Edward Cheng, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Erin Hennessey, BA

507-284-1975 Hennessey.Erin@mayo.edu

Gabe Shouten, BS

(507) 226-5895 Schouten.Gabriel@mayo.edu

Principal Investigator:

Rafael Sierra, MD

NYU Langone Health Orthopedic Hospital

Recruiting

New York, New York, United States, 11016

Contacts

Daniel Waren, CCRP

212-598-6245 daniel.waren@nyulangone.org

Braden Terner

949-400-0017 Braden.terner@nyulangone.org

Principal Investigator:

Ran Scwarzkopf, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 441195

Contacts

Shujaa Khan, MBBS

419-965-8274 khans34@ccf.org

Laura Stiegel, RN, CCRC

216-903-0919 Stiegel@ccf.org

Principal Investigator:

Nicolas Piuzzi, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Helena Moses, BSN

215-294-9166 Helena.Moses@pennmedicine.upenn.edu

Warren Harding, MA

484-802-9675 Warren.Harding@Pennmedicine.upenn.edu

Principal Investigator:

Charles Nelson, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Eric McVey, MEd, CCRP

434-243-5382 EDM9U@uvahealth.org

Laura Simmons, CRA

434-243-5647 LF7H@uvahealth.org

Principal Investigator:

Quanjun Cui, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

osteonecrosis
aseptic necrosis
avascular necrosis (AVN)
bone marrow aspirate
bone marrow aspirate concentrate
bone marrow cells
bone marrow
cell-based treatment
core decompression
femoral head
necrosis
bone diseases
musculoskeletal diseases
pathologic processes
hip
ONFH
AVN

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-11-26.