Effect of HBOT on Femoral Head Avascular Necrosis (AVN)

Starting soon · Not applicable

Conditions studied: Osteonecrosis, Avascular Necrosis

In brief

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.

Key facts

Study ID

NCT06931301

Run by

Yale University

People needed

400

Starts

2026-12-01

Expected to finish

2035-04-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale New Haven Health System — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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