Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
Study NCT ID:
NCT06918860
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Intramedullary Nail and Prosthetic Reconstruction After Surgical Treatment of Bone Metastases of Proximal Femur
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of implant survival', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Assess the longevity associated with the different surgical treatments used for proximal femur bone metastases.'}, {'measure': 'Analysis of complications', 'timeFrame': 'At baseline ( T0)', 'description': 'Assess the post-operative complications associated with the different surgical treatments used for proximal femur bone metastases.'}, {'measure': 'Analysis of functional score', 'timeFrame': '1 year', 'description': 'Assess the functional score associated with the different surgical treatments used for proximal femur bone metastases.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bone metastases', 'proximal femur'], 'conditions': ['Bone Metastases']}, 'referencesModule': {'references': [{'pmid': '16326880', 'type': 'BACKGROUND', 'citation': 'Wedin R, Bauer HC. Surgical treatment of skeletal metastatic lesions of the proximal femur: endoprosthesis or reconstruction nail? J Bone Joint Surg Br. 2005 Dec;87(12):1653-7. doi: 10.1302/0301-620X.87B12.16629.'}, {'pmid': '27650452', 'type': 'BACKGROUND', 'citation': 'Errani C, Mavrogenis AF, Cevolani L, Spinelli S, Piccioli A, Maccauro G, Baldini N, Donati D. Treatment for long bone metastases based on a systematic literature review. Eur J Orthop Surg Traumatol. 2017 Feb;27(2):205-211. doi: 10.1007/s00590-016-1857-9. Epub 2016 Sep 20.'}, {'pmid': '28629828', 'type': 'BACKGROUND', 'citation': 'Araki N, Chuman H, Matsunobu T, Tanaka K, Katagiri H, Kunisada T, Hiruma T, Hiraga H, Morioka H, Hatano H, Asanuma K, Nishida Y, Hiraoka K, Okamoto T, Abe S, Watanuki M, Morii T, Sugiura H, Yoshida Y, Ohno T, Outani H, Yokoyama K, Shimose S, Fukuda H, Iwamoto Y. Factors associated with the decision of operative procedure for proximal femoral bone metastasis: Questionnaire survey to institutions participating the Bone and Soft Tissue Tumor Study Group of the Japan Clinical Oncology Group. J Orthop Sci. 2017 Sep;22(5):938-945. doi: 10.1016/j.jos.2017.05.012. Epub 2017 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will collect data of patients treated surgically for impending or pathological fracture of the proximal femur due to bone metastases between 01/01/2000 and 31/12/2023 with IMN or THA or HHA or MegaTHA or Mega.\n\nAfter pre-screening the databases of the respective sites, the investigators expect to find approximately a total of 600 patients. A review will be made from the medical records, radiological imaging, and histological data of partecipants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female adult patients surgically treated between 01/01/2000 and 31/12/2023 in Rizzoli Orthopaedic Institute and in Massachusetts General Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female adult patients surgically treated between 01/01/2000 and 31/12/2023 in Rizzoli Orthopaedic Institute and in Massachusetts General Hospital.\n* Age ≥18 y (at the time of surgery)\n* Patients with impending or pathological fracture due to bone metastases of the proximal femur (head/neck, intertrochanteric, subtrochanteric area).\n* Patients who underwent either IMN or THA or HHA or Mega or MegaTHA.\n* Patients with available clinical and imaging data.\n\nExclusion Criteria:\n\n* Patients with pathological or impending fracture of proximal femur due to primary bone tumor.'}, 'identificationModule': {'nctId': 'NCT06918860', 'briefTitle': 'Analysis of Intramedullary Nail and Prosthetic Reconstruction After Surgical Treatment of Bone Metastases of Proximal Femur', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Complications, Implant Survival and Functional Results After Surgical Treatment of Bone Metastases of Proximal Femur With Intramedullary Nail or Prosthetic Reconstruction', 'orgStudyIdInfo': {'id': 'BoneMetaProFe'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Male and female adult patients surgically treated between 01/01/2000 and 31/12/2023 in Rizzoli Orthopaedic Institute and in Massachusetts General Hospital.', 'interventionNames': ['Other: Analysis']}], 'interventions': [{'name': 'Analysis', 'type': 'OTHER', 'description': 'Analysis and review of imaging and clinical data', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40134', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Costantino Errani, MD', 'role': 'CONTACT', 'email': 'costantino.errani@ior.it', 'phone': '0516366', 'phoneExt': 'Ext. 103'}, {'name': 'Roberta Laranga, PhD', 'role': 'CONTACT', 'email': 'roberta.laranga@ior.it', 'phone': '0616366', 'phoneExt': '5123'}], 'facility': 'Irccs Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Costantino Errani, MD', 'role': 'CONTACT', 'email': 'costantino.errani@ior.it', 'phone': '0516366', 'phoneExt': 'Ext. 103'}, {'name': 'Roberta Laranga, PhD', 'role': 'CONTACT', 'email': 'roberta.laranga@ior.it', 'phone': '0516366', 'phoneExt': 'Ext. 5123'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Costantino Errani', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Costantino Errani', 'investigatorAffiliation': 'Istituto Ortopedico Rizzoli'}}}}