Effect of HBOT on Femoral Head Avascular Necrosis (AVN)

Yale University

Status: Begins enrollment this month

Conditions: Osteonecrosis; Avascular Necrosis

Treatments: Device: Hyperbaric Oxygen Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06931301

2000038319

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

Hyperbaric Oxygen Therapy- Full Marx Protocol

Experimental group

Description:

30 treatments before surgery, and 10 treatments after surgery

Treatment:

Device: Hyperbaric Oxygen Therapy

Hyperbaric Oxygen Therapy- Reduced Marx Protocol

Experimental group

Description:

20 treatments before surgery and 10 treatments after surgery

Treatment:

Device: Hyperbaric Oxygen Therapy

Control

No Intervention group

Description:

No hyperbaric oxygen therapy

HBOT outside Yale

Experimental group

Description:

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.

Treatment:

Device: Hyperbaric Oxygen Therapy