Osteonecrosis of the Femoral HeadBATONNCT06123481
Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis
A study testing Core Decompression and Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate in people with Osteonecrosis of the Femoral Head and Avascular Necrosis of the Femoral Head, run by Johns Hopkins University at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteonecrosis of the Femoral Head, Avascular Necrosis of the Femoral Head
- What is being tested?
- Core Decompression and Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Apr 2025to 31 Jul 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Participants who have:
- Sickle Cell disease
- Major trauma
- Post-irradiation ON
- Gaucher Disease
- Juvenile form: Legg-Calve-Perthes Disease
Show all 12Show fewer
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Nathaniel Helwig, MD, 410-601-8434, nhelwig@lifebridgehealth.org
Taj-Jamal Andrews, MD, 410-601-9592, tandrews@lifebridgehealth.org
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21224
Lynne C Jones, PhD, 410-550-4001, ljones3@jhmi.edu
Jones
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Eric McVey, MEd, CCRP, 434-243-5382, EDM9U@uvahealth.org
Laura Simmons, CRA, 434-243-5647, LF7H@uvahealth.org
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 441195
Shujaa Khan, MBBS, 419-965-8274, khans34@ccf.org
Laura Stiegel, RN, CCRC, 216-903-0919, Stiegel@ccf.org
- Recruiting
University of Southern California
Los Angeles, California, 90033
Pui Yuk Yan, CCRP, MSCR, MSL, 714-470-0614, puiyan@med.usc.edu
Megan Walsh, MBA, 617-581-7337, megan.walsh@med.usc.edu
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Lobsang Palma, MPH, 612-626-1652, Lobsa006@umn.edu
Annie Paulison, BA, BS, 612-625-3526, pauli098@umn.edu
- Recruiting
NYU Langone Health Orthopedic Hospital
New York, New York, 11016
Daniel Waren, CCRP, 212-598-6245, daniel.waren@nyulangone.org
Braden Terner, 949-400-0017, Braden.terner@nyulangone.org
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Helena Moses, BSN, 215-294-9166, Helena.Moses@pennmedicine.upenn.edu
Warren Harding, MA, 484-802-9675, Warren.Harding@Pennmedicine.upenn.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Erin Hennessey, BA, 507-284-1975, Hennessey.Erin@mayo.edu
Gabe Shouten, BS, (507) 226-5895, Schouten.Gabriel@mayo.edu
- Recruiting
Stanford University
Stanford, California, 94063
Angela N Bye, MA, 650-721-7632, abye@stanford.edu
Stuart B Goodman, MD, PhD, Goodbone@stanford.edu
About this study
Official title: Autologous Bone Marrow Aspirate Concentrate for the Treatment of Osteonecrosis of the Femoral Head
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.
Read the 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.
- Being tested
- Core Decompression, Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate
- 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
- Medical subject headings
- Legg-Calve-Perthes Disease, Femur Head Necrosis, Osteonecrosis, Necrosis, Bone Diseases, Musculoskeletal Diseases, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core DecompressionProcedure or surgery
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 ConcentrateProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Core decompression (CD) | Active comparator | Core decompression of the femoral head with sham bone marrow aspiration Receives: 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. Receives: Procedure: Core Decompression; Procedure: Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Up to 24 months
Secondary outcomes (8)
Change in Pain using the Hip disability and Osteoarthritis Outcome Score (HOOS)
The Pain subscale of the Hip disability and Osteoarthritis Outcome Score (HOOS) will be used. The HOOS Pain sub-score is comprised of 10 items with a potential total of 40 points. Higher score worse pain,
Measured: Baseline, 6 months, 12 months, 24 months
Change in Symptoms and Stiffness using the HOOS
The Symptoms and Stiffness will be assessed using the HOOS Symptoms and Stiffness sub-score is comprised of 5 items with a potential total score of 20 points. Higher score worse stiffness.
Measured: Baseline, 6 months, 12 months, 24 months
Change in Activities of Daily Living function using the HOOS
The HOOS Activities of Daily Living function sub-score is comprised of 17 items with a potential total of 68 points. Higher scores better functioning.
Measured: Baseline, 6 months, 12 months, 24 months
Change in Function in Sports and Recreational Activities using the HOOS
The HOOS Function of Sports and Recreational Activities subscale is comprised of 4 items with a potential total of 16 points. Higher score better outcome.
Measured: Baseline, 6 months, 12 months, 24 months
Change in Quality of Life using the HOOS
The HOOS Quality of Life subscale is comprised of 4 items with a potential total of 16 points. Higher score better quality of life.
Measured: Baseline, 6 months, 12 months, 24 months
Change in Mental Health Composite Score using the PROMIS 10 Global Health Questionnaire
The Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Global Questionnaire is a 10-item patient-reported outcomes measure. A Mental Health Composite Score is generated as a summary of 4 items. Item responses range from 5 = None to 1 = Very Severe. The raw scores are converted into a T-score. Range 0 - 100; Population mean 50, standard deviation 10.
PROMIS mental health survey. The measures are generic, rather than disease-specific, and use an "In General" item context as it is intended to globally reflect individuals' assessment of their health. It is a survey of 10 questions which gives a physical health and mental health score. The raw global health mental score (4-20) is converted to a mental health T score (16.2-67.7). The higher the score, the better the health outcome.
Measured: Baseline, 6 months, 12 months, 24 months
Change in Physical Health Composite Score using the PROMIS 10 Global Health Questionnaire
The Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Global Questionnaire is a 10-item patient-reported outcomes measure. A Physical Health Composite Score is generated from the PROMIS 10 Global Questionnaire as a summary of 4 items. Item responses range from 5 = None to 1 = Very Severe. The raw scores are converted into a T-score. Range 0 - 100; Population mean 50, standard deviation 10.
PROMIS physical health survey. The measures are generic, rather than disease-specific, and use an "In General" item context as it is intended to globally reflect individuals' assessment of their health. It is a survey of 10 questions which gives a physical health and mental health score. The raw global health physical score (4-20) is converted to a physical health T score (16.2-67.7). The higher the score, the better the health outcome.
Measured: Baseline, 6 months, 12 months, 24 months
Change in Activity using the University of California Los Angeles (UCLA) Activity Rating Scale
The UCLA Activity Score ranks the level of participant activity on a 10-point scale based on descriptors of activity ranging from wholly inactive and dependent on others, cannot leave residence (Level 1) to regular participation in impact sports such as tennis, skiing, acrobatics, ballet, heavy labor, or backpacking (Level 10). The higher the level, the better the outcome.
Measured: Baseline, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Apr 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteonecrosis of the Femoral HeadStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Lynne C Jones, PhD, Principal investigator, Johns Hopkins UniversityMichael A Mont, MD, Principal investigator, Sinai Hospital of Baltimore / LifeBridge HealthStuart B Goodman, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123481
- Sponsor's protocol ID
- IRB00289774
- Other IDs
- U01AR080993-01A1
- Acronym
- BATON
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be performed in accordance with the NIH Data Sharing Policy and Guidance document.