Effect of HBOT on Femoral Head Avascular Necrosis (AVN)

NCT06931301 | Not Yet Recruiting FDA Device

• 1 other identifier: 2000038319
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteonecrosis; Avascular Necrosis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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)

  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

  baseline, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years

Study Arms (4)

Hyperbaric Oxygen Therapy- Full Marx Protocol

EXPERIMENTAL

30 treatments before surgery, and 10 treatments after surgery

Device: Hyperbaric Oxygen Therapy

Hyperbaric Oxygen Therapy- Reduced Marx Protocol

EXPERIMENTAL

20 treatments before surgery and 10 treatments after surgery

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.

Device: Hyperbaric Oxygen Therapy

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

HBOT outside Yale; Hyperbaric Oxygen Therapy- Full Marx Protocol; Hyperbaric Oxygen Therapy- Reduced Marx Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Health System

New Haven, Connecticut, 06520, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Osteonecrosis

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Rummana Aslam, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Wiznia

CONTACT

203-785-2579; daniel.wiznia@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 17, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2035
• Study Completion (Estimated): April 1, 2035
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)