Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis

NCT06123481 | Recruiting DMC

• 2 other identifiers: IRB00289774U01AR080993-01A1
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 10

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

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

Outcome Measures

Primary Outcomes (3)

• Radiological progression of osteonecrosis of the femoral head (ONFH) to ARCO Stage III or IV

  The 2019 ARCO Staging System encompasses four stages. ARCO Stage I is the earliest stage of osteonecrosis and is characterized by a normal x-ray and an abnormal MRI. ARCO Stage IV is the most advanced stage of osteonecrosis and is characterized by findings of osteoarthritis on x-ray.

  Up to 24 months

• Change in Pain using the Pain VAS scale

  This is assessed using the pain Visual Analogue Scale (VAS). The participant marks an X on a 10cm scale denoting the level of pain that they are experiencing. VAS measures pain intensity on a scale of 0 (no pain) to 10 (worst pain).

  Up to 24 months

• Time to failure of femoral head

  Time is measured in months following the intervention (core decompression or core decompression with cells). Failure is defined as radiological progression to ARCO Stage III or IV or unremitting pain requiring surgical intervention.

  Up to 24 months

Secondary Outcomes (8)

• Change in Pain using the Hip disability and Osteoarthritis Outcome Score (HOOS)

  Baseline, 6 months, 12 months, 24 months

• Change in Symptoms and Stiffness using the HOOS

  Baseline, 6 months, 12 months, 24 months

• Change in Activities of Daily Living function using the HOOS

  Baseline, 6 months, 12 months, 24 months

• Change in Function in Sports and Recreational Activities using the HOOS

  Baseline, 6 months, 12 months, 24 months

• Change in Quality of Life using the HOOS

  Baseline, 6 months, 12 months, 24 months

Study Arms (2)

Core decompression (CD)

ACTIVE COMPARATOR

Core decompression of the femoral head with sham bone marrow aspiration

Procedure: Core Decompression

Bone Marrow Aspirate Concentrate (BMAC)

EXPERIMENTAL

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

Procedure: Core Decompression; Procedure: Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate

Interventions

Core Decompression 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); Core decompression (CD)

Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate 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.

Bone Marrow Aspirate Concentrate (BMAC)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (10)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Stanford University

Stanford, California, 94063, United States

RECRUITING

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21224, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

NYU Langone Health Orthopedic Hospital

New York, New York, 11016, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 441195, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Legg-Calve-Perthes Disease; Femur Head Necrosis; Osteonecrosis; Necrosis; Bone Diseases; Musculoskeletal Diseases; Pathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Lynne C Jones, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Michael A Mont, MD

  Sinai Hospital of Baltimore / LifeBridge Health

  PRINCIPAL INVESTIGATOR

• Stuart B Goodman, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynne C Jones, PhD

CONTACT

(410) 550-4001; ljones3@jhmi.edu

Stuart Goodman, MD, PhD

CONTACT

650-721-7662; goodbone@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded as to group assignment. Both groups will undergo a core decompression. One group will undergo a bone marrow aspiration and the other group will undergo a sham procedure. This sham procedure consists of a small incision and placing a needle up to the iliac bone but with no bone penetration or aspiration. The study radiologists will be blinded as to patient treatment assignment; images will be assigned the patient study number and date only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 1:1 randomized, parallel design with two treatment arms: 1) core decompression (percutaneous drilling) alone, or 2) core decompression augmented with autogenous bone marrow aspirate. Cluster randomization will be performed at each participating institution.

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: November 8, 2023
• Study Start: April 1, 2025
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: In agreement with the policy of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the data will be shared within 2 years after posting of the study results.
• Access Criteria: 1. Clinicians and scientists will submit final peer-reviewed journal manuscripts. The public will have access to the published results. 2. Requests for subsets of data for sub-analysis will be provided to all Co-Principal Investigators and Co- Investigators following approval of a submitted proposal. 3. A limited access data (LAD) program for public access to a subset of de-identified data from our study will be developed, complying with all the data elements defined by the Health Insurance Portability and Accountability Act of 1996.

Locations

US (10)