Hyperbaric Oxygen Therapy for Avascular Necrosis

Overseen By Daniel Wiznia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Hip collapse, Obesity, Cardiac failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 36

400 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Hyperbaric Oxygen Therapy for Avascular Necrosis?

Research shows that Hyperbaric Oxygen Therapy (HBO) is effective in treating early-stage avascular necrosis (AVN) of the femoral head, with 81% of patients showing improvement on MRI compared to 17% in untreated patients. Additionally, HBO therapy has been shown to reduce inflammation and pain in patients, and in some cases, it has led to complete resolution of AVN in patients with sickle cell disease. ^{1 2 3 4 5}

Is hyperbaric oxygen therapy safe for humans?

The research does not provide specific safety data for hyperbaric oxygen therapy, but it is generally used as a non-invasive treatment, suggesting it is considered safe for humans in the context of treating avascular necrosis. ^{1 2 3 4 6}

How does hyperbaric oxygen therapy differ from other treatments for avascular necrosis?

Hyperbaric oxygen therapy (HBOT) is unique because it involves breathing pure oxygen in a pressurized room, which helps improve blood flow and reduce inflammation in the affected bone. Unlike more invasive treatments, HBOT is noninvasive and can lead to significant improvements in early-stage avascular necrosis, as shown by MRI results and reduced pain levels. ^{1 2 4 5 7}

What is the purpose of this trial?

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.

Research Team

Rummana Aslam, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for individuals enrolled in the Yale Avascular Necrosis Program with early-stage femoral head avascular necrosis (ARCO I or II) who are candidates for core decompression surgery. Participants must consent to all study procedures and be available throughout the study. It excludes pregnant women, prisoners, those without consent, advanced AVN stages (ARCO III or IV), certain medical conditions like severe heart failure or lung disease.

Inclusion Criteria

Provision of signed and dated informed consent form

Enrolled into Yale Avascular Necrosis Program

Avascular necrosis lesion is classified as ARCO I or ARCO II by Investigator

Exclusion Criteria

Pregnant

Prisoner

Does not sign Informed Consent Form

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Hyperbaric Oxygen Therapy

Participants receive Hyperbaric Oxygen Therapy (HBOT) according to the Marx Protocol before surgery

4-6 weeks

20-30 treatments

Surgery and Post-surgery Hyperbaric Oxygen Therapy

Participants undergo core decompression surgery with bone marrow aspirate concentrate and receive additional HBOT sessions

2-3 weeks

10 treatments

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Regular assessments at 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years

Treatment Details

Interventions

• Hyperbaric Oxygen Therapy

Trial Overview The trial tests if Hyperbaric Oxygen Therapy (HBOT) following the Marx Protocol can improve pain when combined with a specific surgical procedure called core decompression using bone marrow concentrate in treating femoral head avascular necrosis.

Participant Groups

Group I: Hyperbaric Oxygen Therapy- Reduced Marx Protocol Experimental Treatment 1 Intervention

20 treatments before surgery and 10 treatments after surgery

Group II: Hyperbaric Oxygen Therapy- Full Marx Protocol Experimental Treatment 1 Intervention

30 treatments before surgery, and 10 treatments after surgery

Group III: HBOT outside Yale Experimental Treatment 1 Intervention

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.

Group IV: Control Active Control 1 Intervention

No hyperbaric oxygen therapy

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy as a treatment for stage-I avascular necrosis of the femoral head. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy ameliorates osteonecrosis in patients by modulating inflammation and oxidative stress. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Avascular necrosis of the femoral head: Evaluation of hyperbaric oxygen therapy and quality of life. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for the treatment of Steinberg I and II avascular necrosis of the femoral head: a report of fifteen cases and literature review. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Complete resolution of stage II avascular necrosis affecting three joints by hyperbaric oxygen in a patient with sickle cell disease: A case report. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy in the treatment of osteonecrosis of the femoral head: a review of the current literature. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Femoral condylar necrosis: treatment with hyperbaric oxygen therapy. [2022]