Bone Marrow Aspirate for Osteonecrosis

(BATON Trial)

Recruiting at 11 trial locations

Overseen By Stuart Goodman, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Sickle cell, Major trauma, Gaucher, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: Immediate post-operative period

192 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Core Decompression with Autologous Bone Marrow Aspirate Concentrate for osteonecrosis?

Research suggests that adding concentrated bone marrow cells to core decompression can help repair and regenerate bone tissue in early stages of osteonecrosis, potentially improving outcomes and reducing the need for hip replacement. ^{1 2 3 4 5}

Is the use of bone marrow aspirate concentrate in core decompression for osteonecrosis safe?

The use of bone marrow aspirate concentrate in core decompression is generally considered a straightforward procedure with low risk for patient harm. ^{1 2 3 6 7}

How is the treatment using core decompression with bone marrow aspirate concentrate different from other treatments for osteonecrosis?

This treatment is unique because it combines core decompression with the injection of concentrated bone marrow cells, which are rich in stem cells that can help regenerate and repair bone tissue, potentially allowing for immediate weight bearing and preserving the natural joint. ^{1 2 3 6 8}

Research Team

Lynne C Jones, PhD

Principal Investigator

Johns Hopkins University

Michael Mont, MD

Principal Investigator

Sinai Hospital of Baltimore / LifeBridge Health

Stuart B Goodman, MD, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for individuals with early-stage osteonecrosis of the femoral head, without subchondral fractures. It includes all lesion sizes and major risk factors except those in the exclusion criteria. Participants must be willing to attend postoperative visits.

Inclusion Criteria

I have a condition where bone tissue in my hip dies without injury.

My bone condition is in the early stages and hasn't caused any fractures.

Be able and willing to participate in the study and return for postoperative visits

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo core decompression with or without autologous bone marrow aspirate concentrate

Immediate post-operative period

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using radiographs, MRIs, and questionnaires

24 months

6 visits (in-person or virtual) at 6, 12, and 24 months

Long-term follow-up

Participants are evaluated for long-term outcomes and survivorship of the femoral head

Beyond 24 months

Treatment Details

Interventions

• Core Decompression
• Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate

Trial Overview The study compares core decompression (CD) alone versus CD enhanced with autologous bone marrow aspirate concentrate in treating early-stage osteonecrosis of the hip. The goal is to see if adding bone marrow improves clinical and radiological outcomes.

Participant Groups

Group I: Bone Marrow Aspirate Concentrate (BMAC) Experimental Treatment 2 Interventions

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

Group II: Core decompression (CD) Active Control 1 Intervention

Core decompression of the femoral head with sham bone marrow aspiration

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

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

Collaborator

Trials

508

Recruited

1,090,000+

Sinai Hospital of Baltimore

Collaborator

Trials

8

Recruited

410+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Core Decompression Augmented With Autologous Bone Marrow Aspiration Concentrate for Early Avascular Necrosis of the Femoral Head. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

The biological basis for concentrated iliac crest aspirate to enhance core decompression in the treatment of osteonecrosis. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Core Decompression with Local Administration of Zoledronate and Enriched Bone Marrow Mononuclear Cells for Treatment of Non-Traumatic Osteonecrosis of Femoral Head. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of osteonecrosis with autologous bone marrow grafting. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Stem cell therapy in bilateral osteonecrosis: computer-assisted surgery versus conventional fluoroscopic technique on the contralateral side. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Surgical Technique: Core Decompression of Femoral Head Osteonecrosis with Bone Marrow Aspirate Concentrate. [2023]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Core Decompression Combined with Implantation of Autologous Bone Marrow Concentrate with Tricalcium Phosphate Does Not Prevent Radiographic Progression in Early Stage Osteonecrosis of the Hip. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Quantitative assessment of mesenchymal stem cells contained in concentrated autologous bone marrow aspirate transplantation for the treatment of osteonecrosis of the femoral head: predictive factors and differences by etiology. [2019]