[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587662":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":57,"collaborators":22,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":22,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":22,"enrollmentInfo":68,"targetDuration":22,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":22,"overallStatus":78,"whyStopped":22,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Yale University","OTHER",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Hyperbaric Oxygen Therapy- Full Marx Protocol","EXPERIMENTAL","30 treatments before surgery, and 10 treatments after surgery",[13],"Device: Hyperbaric Oxygen Therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Hyperbaric Oxygen Therapy- Reduced Marx Protocol","20 treatments before surgery and 10 treatments after surgery",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Control","NO_INTERVENTION","No hyperbaric oxygen therapy",null,{"label":24,"type":10,"description":25,"interventionNames":26},"HBOT outside Yale","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.",[13],[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":22},"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",[24,9,15],[34],{"name":35,"affiliation":5,"role":36},"Rummana Aslam, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":22,"email":42},"Daniel Wiznia","CONTACT","203-785-2579","daniel.wiznia@yale.edu",[44],{"facility":45,"status":22,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":22},"Yale New Haven Health System","New Haven","Connecticut","06520","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-72.92816,41.30815,{"lat":55,"lon":54},{"type":58,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100587662","effect-of-hbot-on-femoral-head-avascular-necrosis-avn-100587662",false,"NCT06931301","Effect of HBOT on Femoral Head Avascular Necrosis (AVN)","Effect of Hyperbaric Oxygen Therapy on Osteonecrosis of the Femoral Head When Combined With 3D Navigated Core Decompression With Bone Marrow Aspirate Concentrate","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Diagnosed with femoral head avascular necrosis\n* Enrolled into Yale Avascular Necrosis Program\n* Avascular necrosis lesion is classified as ARCO I or ARCO II by Investigator\n* Surgical Candidate for Core Decompression using 3D image guidance with bone marrow aspirate concentrate\n\nExclusion Criteria:\n\n* Hip has already collapsed due to severe avascular necrosis (ARCO III or ARCO IV)\n* Medical comorbidities that prevent them from being a surgical candidate (example: obesity)\n* Absolute contraindications to HBOT, including severe decompensated cardiac failure or lung disease putting them at high risk for pneumothorax\n* Pregnant\n* Prisoner\n* Does not sign Informed Consent Form","ALL","18 Years",{"count":69,"type":70},400,"ESTIMATED","INTERVENTIONAL",[73],"NA","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.",[76,77],"Osteonecrosis","Avascular Necrosis","NOT_YET_RECRUITING","2026-06-30",{"date":81,"type":82},"2026-07-01","ACTUAL",{"date":84,"type":70},"2026-12",{"date":86,"type":70},"2035-04",{"name":5,"class":6},1]