[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626351":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":52,"id":56,"slug":20,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":20,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Autograft Bone Harvest","EXPERIMENTAL","Patients undergoing an orthopedic foot and ankle surgery in which an autograft bone harvest will be performed.",[13],"Device: Avitus Bone Harvester",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Avitus Bone Harvester","Patients will receive standard of care treatment, in addition to one extra bone marrow sample obtained using the Avitus Bone Harvester.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Edward T. Haupt, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Edward T Haupt, M.D.","CONTACT","904-953-2496","Haupt.Edward@mayo.edu",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Jacksonville","Florida","32224","United States",{"type":39,"coordinates":40},"Point",[41,42],-81.65565,30.33218,{"lat":42,"lon":41},[45,48],{"name":46,"role":28,"phone":47,"phoneExt":20,"email":20},"Lauren M. Evans","904-953-5416",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":24,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Edward T. Haupt","Principal Investigator",[53],{"name":54,"class":55},"Zimmer Biomet","INDUSTRY","100626351",false,"NCT07434505","Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft","Inclusion Criteria:\n\n* Patient must be 18 years of age or older.\n* Patient must be able and willing to sign the IRB approved informed consent.\n* Patient must consent to preoperative knee and pelvis radiographs to confirm no issue at harvest location.\n* Patient has indication for autograft bone harvest (undergoing any ankle or hindfoot fusion, complex mid and forefoot fusions requiring graft supplementation, treatment of fuse and fracture nonunions)\n* Patient is indicated for proximal tibia autograft harvest and iliac crest BMA (e.g. no hx bilateral TKAs or previous iliac wing trauma bilaterally).\n* Patient is skeletally \"mature\" and presents with no concern for osteopenia\u002Fosteoporosis.\n* Patient has sufficient volume of harvest material for study inclusion (minimum of 10 ml of cancellous bone graft plus 10 ml fluid pressed out from cancellous bone portion)\n* Patient must speak English or have access to sufficient translator.\n\nExclusion Criteria:\n\n* Patient is 70 yrs of age or older.\n* Patient is unwilling or unable to give consent or comply with study protocol.\n* Patient has any condition, which in the judgement of the Investigator, places the patient at undue risk or interferes with the study.\n* Patient has mental or neurological disorder that will not allow for proper informed consent.\n* Patient is known to be pregnant or breastfeeding.\n* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and\u002For anticipated to be non-compliant).\n* Patient has any condition, which in the judgement of the Investigator, may chemically skew bone marrow. This may include but is not limited to the following:\n\n  * Cancer\n  * Undergoing chemotherapy radiation,\n  * Bone marrow transplant\n  * Infection at the donor sites\n  * Organ transplant on antirejection meds\n  * Usage of anti-rheumatologic drugs\n  * Chronic steroid usage\n  * Anemia\n  * Myelodysplastic Syndromes\n* Patient presents with arthritis of the knee and may require knee replacement within the next 12 months.","ALL","18 Years","70 Years",{"count":65,"type":66},12,"ESTIMATED","INTERVENTIONAL",[69],"NA","The purpose of this research is to provide comparative data about the Avitus product and its equivalence to other Bone Marrow Aspirate (BMA) harvesting techniques.",[72],"Bone Graft","2026-02-20",{"date":75,"type":76},"2026-02-25","ACTUAL",{"date":78,"type":76},"2025-11-06",{"date":80,"type":66},"2026-12",{"name":5,"class":6},1]