Effect of HBOT on Femoral Head Avascular Necrosis (AVN)
NCT ID: NCT06931301
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
400 participants
INTERVENTIONAL
2026-03-31
2035-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hyperbaric Oxygen Therapy- Full Marx Protocol
30 treatments before surgery, and 10 treatments after surgery
Hyperbaric Oxygen Therapy
Sechrist Monoplace Hyperbaric Chamber Model 3600, Chamber will be used to supply patients with 100% oxygen to breathe at 2-2.4 ATA (the equivalent of diving to 33 - 45 feet of sea water) for two hours, 5 treatments per week
Hyperbaric Oxygen Therapy- Reduced Marx Protocol
20 treatments before surgery and 10 treatments after surgery
Hyperbaric Oxygen Therapy
Sechrist Monoplace Hyperbaric Chamber Model 3600, Chamber will be used to supply patients with 100% oxygen to breathe at 2-2.4 ATA (the equivalent of diving to 33 - 45 feet of sea water) for two hours, 5 treatments per week
Control
No hyperbaric oxygen therapy
No interventions assigned to this group
HBOT outside Yale
The participant is having HBOT sessions at a different location (outside of the Yale New Haven Health system). These treatments will be overseen by the outside facility's HBOT Director and completed according to the Marx protocol . The patient is responsible for picking a site, setting up their intake appointments, and going to the treatments. The patient is also responsible for providing the HBOT site Director with our protocol as well as returning a completed form that indicates that the proper protocol was used.
Hyperbaric Oxygen Therapy
Sechrist Monoplace Hyperbaric Chamber Model 3600, Chamber will be used to supply patients with 100% oxygen to breathe at 2-2.4 ATA (the equivalent of diving to 33 - 45 feet of sea water) for two hours, 5 treatments per week
Interventions
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Hyperbaric Oxygen Therapy
Sechrist Monoplace Hyperbaric Chamber Model 3600, Chamber will be used to supply patients with 100% oxygen to breathe at 2-2.4 ATA (the equivalent of diving to 33 - 45 feet of sea water) for two hours, 5 treatments per week
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Rummana Aslam, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale New Haven Health System
New Haven, Connecticut, United States
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2000038319
Identifier Type: -
Identifier Source: org_study_id
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