Effect of HBOT on Femoral Head Avascular Necrosis (AVN)

Not Applicable

Not yet recruiting

• Conditions: Osteonecrosis; Avascular Necrosis

• Registration Number: NCT06931301
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Study Start: 2025-06
• Primary Completion: 2035-04
• Study Completion: 2035-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pain scores measured with the Visual Analog Scale (VAS).	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 Outcome Measures

Name	Time	Method
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	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.
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	PROMIS Physical Function measures self-reported capability of physical activities. Scores range from 80-20. A lower T-score represents a worse physical function.
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	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.
Change in ARCO classification	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.

Trial Locations

Locations (1)

Yale New Haven Health System; 🇺🇸 New Haven, Connecticut, United States