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NCT Number: 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 combined with core decompression with autologous bone marrow aspirate concentrate to treat patients with femoral head avascular necrosis.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Health System

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Change in Pain interference PROMIS questionnaire scores

    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

    The PROMIS Pain Interference measures the self-reported consequences of pain on a person's life. Total score range 40 to 80 with higher scores indicating worse outcomes.

  2. Change in Physical function/mobility PROMIS questionnaire scores

    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

    PROMIS Physical Function measures self-reported capability of physical activities. Scores range from 80-20. A lower T-score represents a worse physical function.

  3. Change in Oxford Hip Scores (OHS)

    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

    OHS is an assessment of 12 items of patient-reported outcomes to assess pain and function after hip replacement surgery. Total score range 0 to 48 with higher scores indicating better outcomes.

  4. Change in ARCO classification

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

    Number of Participants that had a change in ARCO 2019 classification using x-rays of hip to determine classification.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Wiznia

CONTACT

[email protected]

203-785-2579

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Effect of Hyperbaric Oxygen Therapy on Osteonecrosis of the Femoral Head When Combined With 3D Navigated Core Decompression With Bone Marrow Aspirate Concentrate

Important dates

Study start
2026
Primary completion
2035
Study completion
2035
First posted
Apr 17, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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