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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Hyperbaric Oxygen Therapy (HBOT) can reduce pain in treating femoral head avascular necrosis, a condition where bone tissue dies due to lack of blood supply. Participants will receive varying amounts of HBOT before and after surgery to determine the most effective approach. Individuals diagnosed with femoral head avascular necrosis and considering surgery at Yale might find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Hyperbaric Oxygen Therapy (HBOT) is generally safe for treating various health issues. Studies have found that HBOT can effectively treat conditions like radiation proctitis, significantly improving healing. Additionally, HBOT is considered safe when combined with standard care, indicating it is well-tolerated by patients.

While HBOT has shown promise in treating femoral head avascular necrosis, not all studies agree on its effectiveness for early stages of this condition. However, its safety record is positive, with side effects being rare or mild. This makes HBOT a potentially safe option for those considering participation in a trial like this one. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about hyperbaric oxygen therapy for avascular necrosis because it offers a potential new approach to support bone healing by increasing oxygen availability in affected tissues. Unlike standard treatments like core decompression or bone grafts that directly address the physical structure, hyperbaric oxygen therapy may enhance the body's natural healing processes through increased oxygenation. This method involves breathing pure oxygen in a pressurized chamber, which is believed to stimulate blood vessel growth and reduce inflammation, potentially providing better outcomes for patients with avascular necrosis. Additionally, by exploring different protocols within the therapy, researchers hope to determine the most effective treatment plan, optimizing both the number of sessions and the timing relative to surgery.

What evidence suggests that this trial's treatments could be effective for avascular necrosis?

This trial will compare different protocols of Hyperbaric Oxygen Therapy (HBOT) for treating avascular necrosis (AVN) of the femoral head. Studies have shown that HBOT might help treat AVN, a condition where bone tissue dies due to lack of blood supply. One study found that HBOT matched the effectiveness of core decompression surgery for early-stage AVN. Another study, which analyzed data collected over 30 years, also supported HBOT's effectiveness for AVN. However, some studies suggest that HBOT might not be effective for early-stage AVN. Overall, while some evidence is positive, results can vary, and more research is needed to confirm HBOT's efficacy for this condition. ^{5 6 7 8 9}

Who Is on the Research Team?

Rummana Aslam, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7889431/

The outcome of hyperbaric oxygen therapy versus core ... This study showed that the HBO is promising and as effective as CD in the treatment of non-traumatic pre-collapsed AVN of the femoral head.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06931301

Effect of HBOT on Femoral Head Avascular Necrosis (AVN) The primary objective of this study is to determine whether the Hyperbaric Oxygen Therapy (HBOT) conducted under the Marx Protocol improves pain outcomes when ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38870950/

The use of hyperbaric oxygen for avascular necrosis ... Hyperbaric oxygen treatment (HBOT) has been shown to be effective in AVN. We present data collected from one centre over a 30-year period ...

4. eor.bioscientifica.com eor.bioscientifica.com/view/journals/eor/10/7/EOR-2024-0167.xml

Application of hyperbaric oxygen therapy in femoral head ... The results of this study indicate that HBOT cannot be regarded as an effective measure for the treatment of early-stage necrosis of the ...

5. uhms.org uhms.org/uhm-search/uhm-journal-volume-51-2024/number-3/hyperbaric-oxygen-therapy-for-avascular-necrosis-of-the-femoral-head-a-case-report.html

Hyperbaric oxygen therapy for avascular necrosis of the ... The outcome of hyperbaric oxygen therapy versus core decompression in the non-traumatic avascular necrosis of the femoral head: Retrospective cohort study.

6. aetna.com aetna.com/cpb/medical/data/100_199/0172.html

Hyperbaric Oxygen Therapy (HBOT) The investigators found HBOT significantly improved chance of healing for radiation proctitis (relative risk 2.7, 95% confidence interval [CI]: 1.2 to 6.0). The ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2049080121000856

The outcome of hyperbaric oxygen therapy versus core ... This study showed that the HBO is promising and as effective as CD in the treatment of non-traumatic pre-collapsed AVN of the femoral head.

8. uhcprovider.com uhcprovider.com/content/dam/provider/docs/public/policies/oxford/hyperbaric-oxygen-therapy-topical-oxygen-therapy-ohp.pdf

Hyperbaric Oxygen Therapy And Topical ... The authors concluded HBOT is a safe and effective treatment option and when used alongside standard trauma care, HBOT appeared to enhance wound ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12232396/

Application of hyperbaric oxygen therapy in femoral head ... Based on the current evidence, HBOT cannot be regarded as an effective measure for the treatment of early-stage necrosis of the femoral head.