Status:
NOT_YET_RECRUITING
Effect of HBOT on Femoral Head Avascular Necrosis (AVN)
Lead Sponsor:
Yale University
Conditions:
Osteonecrosis
Avascular Necrosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to determine whether the Hyperbaric Oxygen Therapy (HBOT) conducted under the Marx Protocol improves pain outcomes when combined with core decompression with aut...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosed with femoral head avascular necrosis
- Enrolled into Yale Avascular Necrosis Program
- Avascular necrosis lesion is classified as ARCO I or ARCO II by Investigator
- Surgical Candidate for Core Decompression using 3D image guidance with bone marrow aspirate concentrate
Exclusion
- Hip has already collapsed due to severe avascular necrosis (ARCO III or ARCO IV)
- Medical comorbidities that prevent them from being a surgical candidate (example: obesity)
- Absolute contraindications to HBOT, including severe decompensated cardiac failure or lung disease putting them at high risk for pneumothorax
- Pregnant
- Prisoner
- Does not sign Informed Consent Form
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2035
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06931301
Start Date
March 1 2026
End Date
April 1 2035
Last Update
December 4 2025
Active Locations (1)
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1
Yale New Haven Health System
New Haven, Connecticut, United States, 06520