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Hyperbaric Oxygen Therapy for Femoral Head Avascular Necrosis

This study is testing if Hyperbaric Oxygen Therapy (HBOT) can improve pain for people with femoral head avascular necrosis (AVN), a condition where bone tissue dies due to lack of blood supply. You would breathe 100% oxygen in a special chamber for two hours, five times a week. Researchers want to see if adding HBOT to a standard surgery (core decompression with bone marrow concentrate) helps reduce pain. To join, you need to be diagnosed with femoral head AVN, be part of the Yale Avascular Necrosis Program, and be a candidate for core decompression surgery. Pain levels will be measured regularly for up to five years. The current status of this study is unclear, and it plans to enroll 400 participants.

Study design
This is an interventional study planning to enroll 400 participants. The phase of the study is not specified.
What's involved
You would receive Hyperbaric Oxygen Therapy (HBOT) for two hours, five times a week. Your pain levels would be measured at several points over five years.
Compensation
Not stated in the trial record.
Follow-up
Your pain will be measured at various times for up to five years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06931301

Effect of HBOT on Femoral Head Avascular Necrosis (AVN)

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Yale University
~400 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Hyperbaric Oxygen Therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pain scores measured with the Visual Analog Scale (VAS).
Measured over baseline, after every 5 treatments of HBOT treatment, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years

Conditions

Osteonecrosis
Avascular Necrosis

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Avascular Necrosis of Femoral Head

NCT06931301

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Yale New Haven Health System

    New Haven, Connecticutno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Rummana Aslam, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Daniel Wiznia
[email protected]
203-785-2579
Email the study team

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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

What this trial measures

  • Change in Pain scores measured with the Visual Analog Scale (VAS).baseline, after every 5 treatments of HBOT treatment, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years

    Participants will be asked to mark a point on a 100 mm horizontal line that represents the intensity of their pain. This line has two endpoints: 0: No pain and 10: Worst possible pain imaginable. The distance from the "0" to the mark is measured in millimeters with the resulting number (0-10) being the VAS pain score.