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Procedure

Bone Marrow Aspirate for Osteonecrosis (BATON Trial)

N/A

Waitlist Available

Led By Stuart B Goodman, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants who have non-traumatic osteonecrosis of the femoral head

Participants who have Stage 1 or 2 ARCO (2019) osteonecrosis with no evidence of subchondral fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, 12 months, 24 months

Awards & highlights

BATON Trial Summary

This trial seeks to find the best treatment for a musculoskeletal disease (ONFH) that causes pain, loss of function and may require hip replacement. It compares different joint-preserving treatments to see which works best.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include pain at the procedure site, infection, bleeding, or blood clots. There might also be risks associated with anesthesia used during surgery.

BATON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I have been diagnosed with femoral head osteonecrosis without known causes.

BATON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, 12 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, 12 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, 12 months, 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Pain using the Pain VAS scale

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

Time to failure of femoral head

Secondary outcome measures

Change in Activities of Daily Living function using the HOOS

Change in Activity using the UCLA Activity Rating Scale

Change in Function in Sports and Recreational Activities using the HOOS

+5 more

BATON Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bone Marrow Aspirate Concentrate (BMAC)Experimental Treatment2 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 Control1 Intervention

Core decompression of the femoral head with sham bone marrow aspiration

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Core Decompression

2014

Completed Phase 2

~60

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,256 Previous Clinical Trials

14,819,879 Total Patients Enrolled

Stanford UniversityOTHER

2,386 Previous Clinical Trials

17,333,816 Total Patients Enrolled

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

483 Previous Clinical Trials

1,086,748 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to join this research endeavor?

"Those wishing to participate in this medical trial should have osteonecrosis of the femoral head and be between 18-90 years old. This clinical study will accept a maximum of 192 individuals."

Answered by AI

Are there numerous medical facilities conducting this research in the U.S.?

"This clinical investigation is being conducted by researchers from Stanford University (Stanford, Maryland), Sinai Hospital of Baltimore (Baltimore, Massachusetts), and Johns Hopkins University (Boston, Minnesota). Additionally, there are a dozen other locations where this trial will be taking place."

Answered by AI

Are there remaining slots for participants in this experiment?

"The details provided by clinicaltrials.gov indicate that this particular medical trial is not currently recruiting patients, with the most recent update occurring on November 6th 2023. Nevertheless, there are 82 other trials actively seeking enrollees at present time."

Answered by AI

What is the purpose of this experiment?

"For this clinical study, the primary outcome that should be observed over 24 months is Pain requiring surgical intervention (hip arthroplasty) as measured by a pain visual analogue scale. Secondary objectives encompass Need for a second surgery which encompasses Progression to ARCO Stages III or IV or unremitting pain necessitating additional medical procedure of hip arthroplasty), Radiological Progression quantified using Association Research Circulation Osseous (ARCO) 2019 Staging System., and Change in Pain subscale of the Hip disability and Osteoarthritis Outcome Score (HOOS)."

Answered by AI