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Oxygen therapy may boost hip procedure for bone death

NCT ID NCT06931301

Disease control Sponsor: Yale University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests whether adding hyperbaric oxygen therapy (breathing pure oxygen in a pressurized chamber) to a standard hip procedure (core decompression with bone marrow cells) can reduce pain in people with early-stage avascular necrosis of the hip. The trial will enroll 400 participants. The goal is to see if the oxygen treatment helps preserve the hip and improve quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Apr 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

avascular necrosis avascular necrosis of femoral head, primary, 1 osteonecrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Avascular necrosis Osteonecrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Yale New Haven Health System

    New Haven, Connecticut, 06520, United States

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