Clinical trial NCT06931301: Effect of HBOT on Femoral Head Avascular Necrosis (AVN)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteonecrosis
Avascular Necrosis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Pain scores measured with the Visual Analog Scale (VAS).
timeFrame: 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 outcomes:
measure: Change in Pain interference PROMIS questionnaire scores
timeFrame: 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: Change in Physical function/mobility PROMIS questionnaire scores
timeFrame: 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: Change in Oxford Hip Scores (OHS)
timeFrame: 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: Change in ARCO classification
timeFrame: baseline, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Health System
state: Connecticut
Study officials:
affiliation: Yale University
name: Rummana Aslam, MD
role: PRINCIPAL_INVESTIGATOR
References: