Effect of Hyperbaric Oxygen Therapy on Osteonecrosis of the Femoral Head When Combined With 3D Navigated Core Decompression With Bone Marrow Aspirate Concentrate
Yale University
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 preve…
Interventions
- DeviceHyperbaric Oxygen Therapy
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
Location
- Yale New Haven Health SystemNew Haven, Connecticut