Effect of HBOT on Femoral Head Avascular Necrosis (AVN)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06931301
Status
Not Yet Recruiting

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Conditions

  • Avascular Necrosis
  • Osteonecrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hyperbaric Oxygen Therapy — DEVICE
    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 Details

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 Dates

Start date
Mar 31, 2026
Status verified
Dec 2025
Primary completion
Apr 30, 2035
Completion
Apr 30, 2035

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hyperbaric Oxygen Therapy- Full Marx Protocol
    30 treatments before surgery, and 10 treatments after surgery
  • Experimental: Hyperbaric Oxygen Therapy- Reduced Marx Protocol
    20 treatments before surgery and 10 treatments after surgery
  • No Intervention: Control
    No hyperbaric oxygen therapy
  • Experimental: HBOT outside Yale
    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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven Health SystemNew HavenConnecticut06520-

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By research site
Yale New Haven Health System· New Haven, CT

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