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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
No Placebo-Only Group

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.
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.
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.

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.
Select...
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.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Change in Activities of Daily Living function using the HOOS
Change in Activity using the University of California Los Angeles (UCLA) Activity Rating Scale
Change in Function in Sports and Recreational Activities using the HOOS
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Stanford UniversityOTHER
2,473 Previous Clinical Trials
17,501,688 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,597 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,089,320 Total Patients Enrolled
~128 spots leftby Apr 2028
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