Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis

NCT ID: NCT06123481

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2029-07-31

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.

Detailed Description

Rationale. It is estimated that there are 10,000 to 20,000 new cases of osteonecrosis of the femoral head diagnosed each year in the United States. Several approaches to treatment have been undertaken including nonsurgical (e.g., pharmaceuticals, hyperbaric oxygen) and surgical (e.g., core decompression, bone grafting (both non-vascularized and vascularized), osteotomies, total joint replacement). Total joint replacement is performed to treat end-stage disease (when the joint goes "out-of-round", and cartilage damage has occurred). There has been increasing interest in using cell-based treatment with core decompression (CD) to treat early-stage osteonecrosis. Bone marrow aspirate concentrate (BMAC) injected into the CD is being evaluated in this study as it contains progenitor cells and other elements that have been shown to facilitate the development of bone and blood vessels. There is a need for rigorous, randomized controlled studies to determine the effectiveness of this cell-based treatment for osteonecrosis of the femoral head (ONFH).

Objectives. The goal of this study is to compare the clinical and radiological results of core decompression with autologous bone marrow aspirate concentrate to core decompression alone (CD). The results will be based on: 1) evidence of radiological progression of ONFH, 2) time to radiological progression of ONFH to Association Research Circulation Osseous (ARCO) Stage III or IV, Association Research Circulation Osseous (ARC)), the international society for the study of osteonecrosis and other disorders of bone circulation] or 3) pain requiring surgical intervention. Success will be based on survivorship of the femoral head over the course of the study. Failure of the procedure is based upon evidence of radiographic progression to ARCO Stage III or pain requiring a surgical intervention.

Overall Design. This is a prospective, multi-center, interventional clinical trial being conducted to evaluate two treatments for early stage ONFH. Participants will be 1:1 randomized to one of two arms: 1) BMAC: Core decompression augmented with autogenous bone marrow aspirate concentrate; 2) CD: Core decompression alone. The core decompression and bone marrow aspiration and concentration will be performed according to a standardized protocol. The CD group will also undergo a sham procedure consisting of a small incision and placing the needle up to the iliac bone without marrow aspiration. In the BMAC group, a sample of the bone marrow aspirate concentrate will be submitted for laboratory assessments to identify the constituent cells and major biological pathways involved. Clinical Research Forms (pre-operatively; 6-, 12-, and 24-months post-operatively), radiographs, and MRIs (pre-operatively; 12- and 24-months post-operatively) will be performed.

Conditions

Osteonecrosis of the Femoral Head; Avascular Necrosis of the Femoral Head

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Core decompression (CD)

Core decompression of the femoral head with sham bone marrow aspiration

Group Type: ACTIVE_COMPARATOR

Core Decompression

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

Core Decompression

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynne C Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Michael A Mont, MD

Role: PRINCIPAL_INVESTIGATOR

Sinai Hospital of Baltimore / LifeBridge Health

Stuart B Goodman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

University of Southern California

Los Angeles, California, United States

Site Status: RECRUITING

Stanford University

Stanford, California, United States

Site Status: RECRUITING

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status: RECRUITING

Johns Hopkins University

Baltimore, Maryland, United States

Site Status: RECRUITING

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status: RECRUITING

NYU Langone Health Orthopedic Hospital

New York, New York, United States

Site Status: RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status: RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lynne C Jones, PhD

Role: CONTACT

ljones3@jhmi.edu

(410) 550-4001

Stuart Goodman, MD, PhD

Role: CONTACT

goodbone@stanford.edu

650-721-7662

Facility Contacts

Pui Yuk Yan, CCRP, MSCR, MSL

Role: primary

puiyan@med.usc.edu

714-470-0614

Megan Walsh, MBA

Role: backup

megan.walsh@med.usc.edu

617-581-7337

Angela N Bye, MA

Role: primary

abye@stanford.edu

650-721-7632

Stuart B Goodman, MD, PhD

Role: backup

Goodbone@stanford.edu

Nathaniel Helwig, MD

Role: primary

nhelwig@lifebridgehealth.org

410-601-8434

Taj-Jamal Andrews, MD

Role: backup

tandrews@lifebridgehealth.org

410-601-9592

Anirudh Buddhiraju, MD

Role: primary

abuddhi1@jhmi.edu

551-271-6992

Lynne C Jones, PhD

Role: backup

ljones3@jhmi.edu

410-550-4001

Lobsang Palma, MPH

Role: primary

Lobsa006@umn.edu

612-626-1652

Annie Paulison, BA, BS

Role: backup

pauli098@umn.edu

612-625-3526

Erin Hennessey, BA

Role: primary

Hennessey.Erin@mayo.edu

507-284-1975

Gabe Shouten, BS

Role: backup

Schouten.Gabriel@mayo.edu

(507) 226-5895

Daniel Waren, CCRP

Role: primary

daniel.waren@nyulangone.org

212-598-6245

Braden Terner

Role: backup

Braden.terner@nyulangone.org

949-400-0017

Shujaa Khan, MBBS

Role: primary

khans34@ccf.org

419-965-8274

Laura Stiegel, RN, CCRC

Role: backup

Stiegel@ccf.org

216-903-0919

Helena Moses, BSN

Role: primary

Helena.Moses@pennmedicine.upenn.edu

215-294-9166

Warren Harding, MA

Role: backup

Warren.Harding@Pennmedicine.upenn.edu

484-802-9675

Eric McVey, MEd, CCRP

Role: primary

EDM9U@uvahealth.org

434-243-5382

Laura Simmons, CRA

Role: backup

LF7H@uvahealth.org

434-243-5647

Other Identifiers

U01AR080993-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00289774

Identifier Type: -

Identifier Source: org_study_id