Effect of HBOT on Femoral Head Avascular Necrosis (AVN)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Hyperbaric Oxygen Therapy
Treatment groups
400 Participants
are divided into 4 treatment groupsLocations
1Yale New Haven Health System06520, New HavenConnecticut, United States
Sponsors and collaborators
Yale University
Lead sponsor
Source ClinicalTrials.gov