OsteonecrosisNCT06931301
Effect of HBOT on Femoral Head Avascular Necrosis (AVN)
A study testing Hyperbaric Oxygen Therapy in people with Osteonecrosis and Avascular Necrosis, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteonecrosis, Avascular Necrosis
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Apr 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yale New Haven Health System
New Haven, Connecticut, 06520
About this study
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
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.
- Conditions
- Osteonecrosis, Avascular Necrosis
- Being tested
- Hyperbaric Oxygen Therapy
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Therapy- Full Marx Protocol | Experimental | 30 treatments before surgery, and 10 treatments after surgery Receives: Device: Hyperbaric Oxygen Therapy |
| Hyperbaric Oxygen Therapy- Reduced Marx Protocol | Experimental | 20 treatments before surgery and 10 treatments after surgery Receives: Device: Hyperbaric Oxygen Therapy |
| Control | No intervention | No hyperbaric oxygen therapy |
| HBOT outside Yale | Experimental | 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. Receives: Device: Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain scores measured with the Visual Analog Scale (VAS).
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.
Measured: 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
Secondary outcomes (4)
Change in Pain interference PROMIS questionnaire scores
The PROMIS Pain Interference measures the self-reported consequences of pain on a person's life. Total score range 40 to 80 with higher scores indicating worse outcomes.
Measured: 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
Change in Physical function/mobility PROMIS questionnaire scores
PROMIS Physical Function measures self-reported capability of physical activities. Scores range from 80-20. A lower T-score represents a worse physical function.
Measured: 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
Change in Oxford Hip Scores (OHS)
OHS is an assessment of 12 items of patient-reported outcomes to assess pain and function after hip replacement surgery. Total score range 0 to 48 with higher scores indicating better outcomes.
Measured: 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
Change in ARCO classification
Number of Participants that had a change in ARCO 2019 classification using x-rays of hip to determine classification.
Measured: baseline, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study startDec 2026 (estimated)
- Primary completionApr 2035 (estimated)
- Study completionApr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteonecrosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants with femoral head avascular necrosis having core decompression surgery using 3D modeling techniques with autologous bone marrow aspirate concentrate through the Yale Avascular Necrosis and Osteonecrosis Program. Participants will be able to choose which arm they wish to enroll in by participating in shared clinical decision making with the provider.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rummana Aslam, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931301
- Sponsor's protocol ID
- 2000038319
- Status last verified
- Jun 2026
- First submitted
- 8 Apr 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06931301
- Acronym / sponsor ID
- 2000038319
- Conditions
- Osteonecrosis, Avascular Necrosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Apr 2035 (estimated)
- Study completion
- Apr 2035 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants with femoral head avascular necrosis having core decompression surgery using 3D modeling techniques with autologous bone marrow aspirate concentrate through the Yale Avascular Necrosis and Osteonecrosis Program. Participants will be able to choose which arm they wish to enroll in by participating in shared clinical decision making with the provider.
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Therapy- Full Marx Protocol | Experimental | Device: Hyperbaric Oxygen Therapy30 treatments before surgery, and 10 treatments after surgery |
| Hyperbaric Oxygen Therapy- Reduced Marx Protocol | Experimental | Device: Hyperbaric Oxygen Therapy20 treatments before surgery and 10 treatments after surgery |
| Control | No intervention | –No hyperbaric oxygen therapy |
| HBOT outside Yale | Experimental | Device: Hyperbaric Oxygen TherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TherapySechrist 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 | Device | HBOT outside Yale, Hyperbaric Oxygen Therapy- Full Marx Protocol, Hyperbaric Oxygen Therapy- Reduced Marx Protocol |
Primary outcome
Change in Pain scores measured with the Visual Analog Scale (VAS).
Time frame: 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.
4 secondary outcomes
Change in Pain interference PROMIS questionnaire scores
Time frame: 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
Change in Physical function/mobility PROMIS questionnaire scores
Time frame: 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
Change in Oxford Hip Scores (OHS)
Time frame: 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
Change in ARCO classification
Time frame: baseline, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rummana Aslam, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy in people with Osteonecrosis and Avascular Necrosis, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Wiznia (203-785-2579, daniel.wiznia@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain scores measured with the Visual Analog Scale (VAS). (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.