Effect of HBOT on Femoral Head Avascular Necrosis (AVN)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperbaric Oxygen Therapy.
- Who it may be relevant to
- Registry conditions: Osteonecrosis, Avascular Necrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Hyperbaric Oxygen Therapy on Osteonecrosis of the Femoral Head When Combined With 3D Navigated Core Decompression With Bone Marrow Aspirate Concentrate
Overview
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
- Device Hyperbaric 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
Primary outcome measures
- Change in Pain scores measured with the Visual Analog Scale (VAS). [Time frame: 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]
Secondary outcome measures (4)
- Change in Pain interference PROMIS questionnaire scores [Time frame: 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 Physical function/mobility PROMIS questionnaire scores [Time frame: 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) [Time frame: 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 [Time frame: baseline, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Yale New Haven Health System — New Haven
Identifiers
NCT: NCT06931301 · 2000038319