Effect of HBOT on Femoral Head Avascular Necrosis (AVN)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hyperbaric Oxygen Therapy
DeviceSechrist 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
Treatment groups
400 Participants
are divided into 4 treatment groupsGroup A: Hyperbaric Oxygen Therapy- Full Marx ProtocolExperimental treatment 1 intervention
Group B: Hyperbaric Oxygen Therapy- Reduced Marx ProtocolExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions
Group D: HBOT outside YaleExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
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 yearsSecondary outcomes
1
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.
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 years2
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.
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 years3
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.
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 years4
Change in ARCO classification
Number of Participants that had a change in ARCO 2019 classification using x-rays of hip to determine classification.
Time frame
baseline, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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