Effect of HBOT on Femoral Head Avascular Necrosis (AVN)
Launched by YALE UNIVERSITY · Apr 8, 2025
Trial Information
Current as of June 03, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of Hyperbaric Oxygen Therapy (HBOT) combined with a surgical procedure called core decompression to help relieve pain for patients with a condition known as femoral head avascular necrosis (AVN). AVN occurs when there is a loss of blood supply to the bone in the hip, which can lead to severe pain and potential joint collapse. The goal of this study is to see if adding HBOT can improve pain relief for patients undergoing this treatment.
To participate in the trial, individuals must be between the ages of 65 and 74 and have been diagnosed with femoral head AVN. They should also be eligible for the core decompression surgery. Participants will need to provide consent to join the study and agree to follow all procedures throughout its duration. However, those with advanced AVN where the hip has collapsed, or with certain medical conditions that could complicate surgery, may not be eligible. This trial is not yet open for recruitment, but it aims to help improve treatment options for individuals suffering from this painful condition.
Gender
ALL
Eligibility 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
About Yale University
Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Haven, Connecticut, United States
Patients applied
Trial Officials
Rummana Aslam, MD
Principal Investigator
Yale University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported