Avascular Necrosis, Osteonecrosis
Conditions
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.
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
Sponsors
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants with femoral head avascular necrosis having core decompression surgery using 3D modeling techniques with autologous bone marrow aspirate concentrate through the Yale Avascular Necrosis and Osteonecrosis Program. Participants will be able to choose which arm they wish to enroll in by participating in shared clinical decision making with the provider.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain scores measured with the Visual Analog Scale (VAS). | baseline, after every 5 treatments of HBOT treatment, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years | Participants will be asked to mark a point on a 100 mm horizontal line that represents the intensity of their pain. This line has two endpoints: 0: No pain and 10: Worst possible pain imaginable. The distance from the "0" to the mark is measured in millimeters with the resulting number (0-10) being the VAS pain score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain interference PROMIS questionnaire scores | baseline, after every 5 treatments of HBOT treatment, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years | The PROMIS Pain Interference measures the self-reported consequences of pain on a person's life. Total score range 40 to 80 with higher scores indicating worse outcomes. |
| Change in Physical function/mobility PROMIS questionnaire scores | baseline, after every 5 treatments of HBOT treatment, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years | PROMIS Physical Function measures self-reported capability of physical activities. Scores range from 80-20. A lower T-score represents a worse physical function. |
| Change in Oxford Hip Scores (OHS) | baseline, after every 5 treatments of HBOT treatment, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years | OHS is an assessment of 12 items of patient-reported outcomes to assess pain and function after hip replacement surgery. Total score range 0 to 48 with higher scores indicating better outcomes. |
| Change in ARCO classification | baseline, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years | Number of Participants that had a change in ARCO 2019 classification using x-rays of hip to determine classification. |
Countries
United States
Contacts
CONTACTDaniel Wiznia
PRINCIPAL_INVESTIGATORRummana Aslam, MD
Yale University
Outcome results
None listed