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NCT06931301 | NOT YET RECRUITING | Osteonecrosis

Effect of HBOT on Femoral Head Avascular Necrosis (AVN)
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.

Condition or disease

Osteonecrosis

Avascular Necrosis

Intervention/treatment

Hyperbaric Oxygen Therapy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 400 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Effect of Hyperbaric Oxygen Therapy on Osteonecrosis of the Femoral Head When Combined With 3D Navigated Core Decompression With Bone Marrow Aspirate Concentrate
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2035-04
Estimated Study Completion Date : 2035-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Effect of HBOT on Femoral Head Avascular Necrosis (AVN)

Location Details

NCT06931301

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How to Participate

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Locations

Not yet recruiting

United States, Connecticut

Yale New Haven Health System

New Haven, Connecticut, United States, 06520