Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-26 @ 3:13 PM
Study NCT ID:
NCT03416959
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2018-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Metastases Database of Patients Treated Surgically for Impending or Pathologic Fracture of Long Bones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2018-01-11', 'studyFirstSubmitQcDate': '2018-01-24', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Prognostic factor regarding erythrocyte sedimentation rate', 'timeFrame': '24 months', 'description': 'erythrocyte sedimentation rate (mm/h)'}, {'measure': 'Prognostic factor regarding C reactive protein', 'timeFrame': '24 months', 'description': 'C reactive protein (mg/dl)'}, {'measure': 'Prognostic factor regarding Alkaline phosphatase', 'timeFrame': '24 months', 'description': 'Alkaline phosphatase (U/L)'}, {'measure': 'Prognostic factor regarding white blood cells', 'timeFrame': '24 months', 'description': 'white blood cells (10/mm)'}, {'measure': 'Prognostic factor regarding hemoglobin', 'timeFrame': '24 months', 'description': 'hemoglobin (g/dl)'}, {'measure': 'Prognostic factor regarding Karnofsky score', 'timeFrame': '24 months', 'description': 'Karnofsky score (0/100)'}], 'primaryOutcomes': [{'measure': 'Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction', 'timeFrame': '24 months', 'description': 'The study includes the collection of clinical data (age, sex, Karnofsky score) and laboratory data related to the patient (erythrocyte sedimentation rate, C reactive protein, Alkaline phosphatase, white blood cells and hemoglobin) at the time of admission, data on the pathology (histotype, site of bone metastasis , presence of further skeletal or visceral metastases), type of surgery performed (stabilization versus resection).The objectives of this study is to examine clinical outcomes after after surgical treatment of bone metastases with a specific focus on differences in complication rate between patients treated with intramedullary nail versus endoprosthetic reconstruction'}], 'secondaryOutcomes': [{'measure': 'Survival in patients undergoing surgery for metastatic bone disease', 'timeFrame': '24 months', 'description': 'Provide a reliable and objective means of estimating survival in patients with metastatic bone disease based on disease-specific and laboratory tests'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasm Metastasis']}, 'descriptionModule': {'briefSummary': 'The aims of this study are to collect prospective data on the natural history of bone metastases (BMs) and skeleta related events (SREs),', 'detailedDescription': 'The aims of this study are to evaluate clinical and biological factors of patients with BMs after reconstruction with intramedullary fixation (IMN) or endoprosthetic reconstruction (EPR) with a specific focus on (1) the rate of complication or failure; (2) differences in complication rates by anatomic site; (3) functional results as assessed by the Musculoskeletal Tumor Society System (MSTS); (4) differences in complication rate between patients treated with INM versus EPR; and (5) differences in survival in patients with metastatic bone disease based on disease-specific, laboratory, and demographic information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with bone metastases in the extremities treated with intramedullary fixation or endoprosthetic recosntruction for impending fracture or pathologic fracture', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with long bone metastases treated surgically with intramedullary nail or endoprosthetic reconstruction\n\nExclusion Criteria:\n\n* Patients with bone metastases of the spine'}, 'identificationModule': {'nctId': 'NCT03416959', 'acronym': 'BMD', 'briefTitle': 'Bone Metastases Database of Patients Treated Surgically for Impending or Pathologic Fracture of Long Bones', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Prospective Bone Metastases Database', 'orgStudyIdInfo': {'id': '0012807'}}, 'armsInterventionsModule': {'interventions': [{'name': 'intramedullary fixation or endoprosthetic reconstruction', 'type': 'PROCEDURE', 'description': 'Surgical treatment for long bone metastases with intramedullary nail or endoprosthetic reconstruction'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'state': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Costantino Errani, MD, PhD', 'role': 'CONTACT', 'email': 'costantino.errani@ior.it', 'phone': '0039 051 6366103'}, {'name': 'Davide Donati, MD', 'role': 'CONTACT', 'email': 'davidemaria.donati@ior.it', 'phone': '0039 051 6366012'}], 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Costantino Errani, MD', 'role': 'CONTACT', 'email': 'costantino.errani@ior.it', 'phone': '+390516366103'}, {'name': 'Davide M Donati, MD', 'role': 'CONTACT', 'email': 'davidemaria.donati@ior.it', 'phone': '+390516366012'}], 'overallOfficials': [{'name': 'Costantino Errani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Ortopedico Rizzoli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will be published in the international literature at the end of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD.', 'investigatorFullName': 'Costantino Errani', 'investigatorAffiliation': 'Istituto Ortopedico Rizzoli'}}}}