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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric Oxygen Therapy- Full Marx Protocol | Experimental | 30 treatments before surgery, and 10 treatments after surgery |
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| Hyperbaric Oxygen Therapy- Reduced Marx Protocol | Experimental | 20 treatments before surgery and 10 treatments after surgery |
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| Control | No Intervention | No hyperbaric oxygen therapy | |
| HBOT outside Yale | Experimental | The participant is having HBOT sessions at a different location (outside of the Yale New Haven Health system). These treatments will be overseen by the outside facility's HBOT Director and completed according to the Marx protocol . The patient is responsible for picking a site, setting up their intake appointments, and going to the treatments. The patient is also responsible for providing the HBOT site Director with our protocol as well as returning a completed form that indicates that the proper protocol was used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen Therapy | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain scores measured with the Visual Analog Scale (VAS). | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain interference PROMIS questionnaire scores | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Wiznia | Contact | 203-785-2579 | daniel.wiznia@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rummana Aslam, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Health System | New Haven | Connecticut | 06520 | United States |
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| Label | URL |
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| Related Info | View source |
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| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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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.
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| Change in Physical function/mobility PROMIS questionnaire scores | PROMIS Physical Function measures self-reported capability of physical activities. Scores range from 80-20. A lower T-score represents a worse physical function. | 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 |
| Change in Oxford Hip Scores (OHS) | 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. | 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 |
| Change in ARCO classification | Number of Participants that had a change in ARCO 2019 classification using x-rays of hip to determine classification. | baseline, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |