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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for early-stage osteonecrosis of the femoral head, a painful hip condition where bone tissue dies and can lead to arthritis. One group will receive a standard procedure called core decompression. The other group will undergo the same procedure with added bone marrow cells from the patient, known as the Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate, to improve healing. The trial aims to determine which treatment better prevents the condition from worsening. Ideal candidates for this study have early-stage osteonecrosis without bone fractures and can undergo MRI scans. As an unphased trial, this study allows patients to contribute to medical research that may enhance future treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that treatments using core decompression with bone marrow aspirate concentrate are generally safe for patients. Studies have found that core decompression alone helps 60% to 80% of patients over time. Adding bone marrow aspirate concentrate maintains safety, with no major safety issues reported. This method uses the patient's own bone marrow, which is concentrated and injected into the affected area, reducing the risk of rejection or serious side effects.

Overall, both parts of the treatment—core decompression and the addition of bone marrow aspirate—are well-tolerated. Studies have not reported any significant adverse events. This suggests the treatment is safe for people with early-stage osteonecrosis, a condition where bone tissue dies due to a lack of blood supply. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the use of Bone Marrow Aspirate Concentrate (BMAC) for osteonecrosis because it offers a regenerative approach that standard treatments do not. Unlike traditional methods that primarily focus on relieving pressure in the bone, BMAC involves injecting concentrated autologous bone marrow directly into the affected area, potentially enhancing bone healing and regeneration. This method leverages the body's own stem cells to repair damaged tissue, offering a promising alternative to current options that may only provide symptomatic relief. Additionally, this approach could lead to improved outcomes by directly targeting the underlying cause of bone degeneration.

What evidence suggests that this trial's treatments could be effective for osteonecrosis?

Research has shown that combining core decompression with a patient's own bone marrow cells (BMAC) offers a promising treatment for osteonecrosis of the femoral head (ONFH). In this trial, one group of participants will receive core decompression with BMAC, while another group will undergo core decompression alone. Studies have found that this combination can reduce pain and improve movement in patients. Specifically, one study showed that core decompression alone succeeded in 53% to 71% of cases, indicating room for improvement. Adding BMAC has been linked to better outcomes, making it a more effective and cost-efficient option. This method might provide a safer and less invasive alternative to joint replacement, especially for younger patients. ^{1 2 3 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4821226/

Core Decompression and Autologous Bone Marrow ... Based on the data by Mont et al., core decompression leads to clinical success in 53-71% of treated patients leaving room for further therapy improvement.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0976566221005750

Core decompression and bone marrow aspirate ... A review of the clinical data demonstrates improvements in pain and functional outcomes when patients with knee osteoarthritis were treated with MSCs, ...

3. academic.oup.com academic.oup.com/jhps/article/11/4/263/7758090

Is core decompression and bone marrow concentrate with ... The aim of this article is to determine the safety and efficacy of core decompression (CD) combined with injection of autologous bone marrow

4. jocr.co.in jocr.co.in/wp/2024/08/core-decompression-with-bone-marrow-aspirate-concentrate-implantation-in-osteonecrosis-of-the-femoral-head-with-a-minimum-of-2-year-follow-up-a-pilot-study/

Core Decompression with Bone Marrow Aspirate ... Conclusion: Core decompression with BMAC implantation emerges as a promising, effective, and safe treatment for ONFH with better cost-effectiveness and minimal ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06123481

Autologous Bone Marrow Aspirate Treatment for Early- ... Objectives. The goal of this study is to compare the clinical and radiological results of core decompression with autologous bone marrow aspirate concentrate to ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2212628716000463

Core Decompression Augmented With Autologous Bone ... The purpose of this article was to describe our method of core decompression augmented with bone marrow aspirate concentrate and bone grafting for the treatment ...

7. aetna.com aetna.com/cpb/medical/data/700_799/0753.html

Core Decompression for Avascular Necrosis Results have varied; however, a 60 % to 80 % success rate has been achieved at 5- to 10-year follow-up. Other techniques such as infusion/implantation of ...