Avascular Necrosis Clinical Trial

“Effect of Hyperbaric Oxygen Therapy on Osteonecrosis of the Femoral Head When Combined with 3D Navigated Core Decompression with Bone Marrow Aspirate Concentrate”

What is Avascular Necrosis

Avascular Necrosis (AVN) of the femoral head, also known as osteonecrosis, is a condition where the blood supply to the hip joint is injured. When the small blood vessels in the femoral head are damaged, the bone does not receive the nutrients it needs, so it cannot repair itself. Each year, about 20,000 new cases of AVN of the femoral head are diagnosed in the United States. People with this condition might face painful symptoms, such as the collapse of the femoral head, which sometimes requires that the patient receives a total hip replacement.

AVN is often found in people between the ages of 15 and 65. Up to 67% of people with AVN of the femoral head eventually develop symptoms. When the femoral head collapses, the best treatment is usually a total hip replacement, also called total hip arthroplasty (THA). However, younger patients who have a hip replacement are likely to face more problems because they are more active and will use the hip implant for a longer time. That’s why it is important to find ways to prevent the hip from collapsing in the first place, to avoid needing a total hip replacement.

AVN Program Co-Directors

Drs. Rummana Aslam and Daniel Wiznia co-direct the Avascular Necrosis / Osteonecrosis Program at Yale. The program has developed unique techniques for the treatment of avascular necrosis, including minimally invasive, 3D navigated core decompression surgery, the use of stems cells, and hyperbaric oxygen therapy (HBOT). Their goal is to conduct research focused on preventing femoral head collapse.

HIC#2000038319

Principal Investigators

About this Clinical Trial

This study will help determine how different amounts of hyperbaric oxygen therapy effect osteonecrosis of the femoral head. We are applying a well-known hyperbaric oxygen therapy protocol developed by Dr. Marx to treat mandibular osteoradionecrosis, and applying his findings to treat femoral head osteo necrosis. The Marx protocol involves having 30 hyperbaric oxygen treatments before core decompression surgery, and 10 treatments after surgery. There is also a reduced version that involves 20 treatments before surgery, and 10 after surgery. In this Yale study we are comparing pain, hip function, and whether the hip collapses and the patient requires a total hip replacement based on the different treatment options: the full Marx protocol, the reduced Marx protocol, and no hyperbaric oxygen therapy. For patients who are not able to travel to Yale University to undergo their hyperbaric oxygen therapy, patients will be able to have therapy outside of the Yale network closer to their homes. Shared decision-making will be used to determine which treatment group is best for each patient's unique situation.

The current standard of care treatment for avascular necrosis is a core decompression, but studies have shown that combining HBOT and a core decompression may lead to the best patient recovery and chance to maintain their native joint and prevent collapse. During hyperbaric oxygen treatments, patients are placed in a chamber with 100 percent oxygen at elevated pressure for two hours, five days per week, for 6-8 weeks. The high levels of oxygen allow for stem cells to have an increased potential to regenerate new blood vessels, bone cells, and collagen fibers to repair the femoral head. HBOT can be time consuming and may require the patient to temporarily relocate and take time off from work to receive treatment.

How to Enroll

Patients are evaluated by Drs. Wiznia and Aslam to determine if they are appropriate candidates for the clinical trial. Hip imaging such as x-rays, MRIs, and CT scans are reviewed to determine if the patient is appropriate for the trial. Subsequently, in person or telehealth consultations are conducted. If the patient fulfills all the inclusion and exclusion criteria, the patient will be asked to enroll by the Yale Center for Clinical Investigation.

If you are interested in participating in the 3D computer navigated core decompression and hyperbaric oxygen therapy clinical trial, call 1-877-925-3637 to request an appointment or refer a patient to the AVN Program.

Patients may fill out this form and will be contacted by our team to schedule a consultation.