Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT00160758
Status:
COMPLETED
Last Update Posted:
2012-10-30
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Characteristics of Retrieved Massive Allografts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001859', 'term': 'Bone Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-26', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bone Cancer']}, 'descriptionModule': {'briefSummary': 'This purpose of this study is to measure the strength of tissue allografts that have been in the body various lengths of time.', 'detailedDescription': 'Allograft bone is the primary source of graft material for large skeletal defects resulting from trauma, disease, oncological resection, or reconstruction of failed total joint arthroplasties. The physical characteristics of such grafts after various intervals of remodeling and incorporation in vivo have never been studied.\n\nThe purpose of this study is to obtain tissue from allografts retrieved at autopsy, at amputation for oncological complications and from patients undergoing revision procedures for failed allograft transplantation. We will evaluate the mechanical properties, histomorphometric indices and presence of microfractures.\n\nOur hypotheses are:\n\n* histomorphometric parameters of porosity and microfracture density will predict allograft strength,\n* microfracture density will be correlated with time in vivo and allograft strength,\n* the rate of host-allograft nonunion and fracture will correlate with radiation therapy and chemotherapy.\n\nThe retrieved tissue will be processed using standard undecalcified histology and quantitatively assessed for degree of incorporation, allograft porosity, and microfracture density. The biomechanical characteristics of the bulk allograft and allograft-host junction will be quantified and compared to allograft bone prior to transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Orthopaedic clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* failed allograft bone\n* removal of allograft due to oncological complications\n* amputation due to oncological complications\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT00160758', 'briefTitle': 'Physical Characteristics of Retrieved Massive Allografts', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Physical Characteristics of Retrieved Massive Allografts', 'orgStudyIdInfo': {'id': '214-1999'}}, 'armsInterventionsModule': {'interventions': [{'name': 'retrieve massive allograft', 'type': 'PROCEDURE', 'description': 'Allograft constructs removed because of infection or cancer complications will be retained for biomechanical testing'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Orthopaedics and Sports Medicine Institute', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Mark T. Scarborough, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}