Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:55 AM
Study NCT ID:
NCT07434505
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of Cells Present', 'timeFrame': 'Until the end of the study (approximately 18 months)', 'description': 'characterize what present cells can do'}], 'secondaryOutcomes': [{'measure': 'Cellular Component', 'timeFrame': 'Until the end of the study (approximately 18 months)', 'description': 'Analysis of cellular components through counting, flow cytometry, and filtration of each sample type.'}, {'measure': 'Bone Growth Capacity', 'timeFrame': 'Until the end of study (approximately 18 months)', 'description': 'Analysis of the bone formation capacity of each sample type through measurement of growth factors and protein components.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Bone Graft']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/osteoporosis.\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/or 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.'}, 'identificationModule': {'nctId': 'NCT07434505', 'briefTitle': 'Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft', 'orgStudyIdInfo': {'id': '24-007124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autograft Bone Harvest', 'description': 'Patients undergoing an orthopedic foot and ankle surgery in which an autograft bone harvest will be performed.', 'interventionNames': ['Device: Avitus Bone Harvester']}], 'interventions': [{'name': 'Avitus Bone Harvester', 'type': 'DEVICE', 'description': 'Patients will receive standard of care treatment, in addition to one extra bone marrow sample obtained using the Avitus Bone Harvester.', 'armGroupLabels': ['Autograft Bone Harvest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren M. Evans', 'role': 'CONTACT', 'phone': '904-953-5416'}, {'name': 'Edward T. Haupt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'centralContacts': [{'name': 'Edward T Haupt, M.D.', 'role': 'CONTACT', 'email': 'Haupt.Edward@mayo.edu', 'phone': '904-953-2496'}], 'overallOfficials': [{'name': 'Edward T. Haupt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Edward T. Haupt', 'investigatorAffiliation': 'Mayo Clinic'}}}}