Effect of HBOT on Femoral Head Avascular Necrosis (AVN)
Key facts
- Who runs it
- Yale University
- Where
- New Haven, United StatesSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 400 people, planned
- Starts
- Dec 2026
- Expected to end
- Apr 2035
- Type of study
- Interventional, 4 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Hyperbaric Oxygen Therapy
- Record updated
- 1 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Hip has already collapsed due to severe avascular necrosis (ARCO III or ARCO IV)
- Pregnant
- Prisoner
- Does not sign Informed Consent Form
Where in United States
- Yale-New Haven Health SystemNew Haven, United StatesContact: Daniel WizniaNot yet recruiting
About the trial
What the trial wants to find out
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 autologous bone marrow aspirate concentrate to treat patients with femoral head avascular necrosis.
The 4 groups in the trial
- Hyperbaric Oxygen Therapy- Full Marx ProtocolTreatment being tested
30 treatments before surgery, and 10 treatments after surgery
Treatment: Hyperbaric Oxygen Therapy
- Hyperbaric Oxygen Therapy- Reduced Marx ProtocolTreatment being tested
20 treatments before surgery and 10 treatments after surgery
Treatment: Hyperbaric Oxygen Therapy
- ControlNo study treatment, for comparison
No hyperbaric oxygen therapy
- HBOT outside YaleTreatment being tested
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.
Treatment: Hyperbaric Oxygen Therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Hyperbaric Oxygen Therapy on Osteonecrosis of the Femoral Head When Combined With 3D Navigated Core Decompression With Bone Marrow Aspirate Concentrate
- Record updated
- 1 July 2026