Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 10:58 AM
Study NCT ID:
NCT07326969
Status:
COMPLETED
Last Update Posted:
2026-01-08
First Post:
2025-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MOVEMENT ANALYSIS IN PATIENTS UNDERGOING VERTEBRECTOMIES FOR SPINE ONCOLOGY: A PILOT STUDY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-24', 'studyFirstSubmitDate': '2025-12-24', 'studyFirstSubmitQcDate': '2025-12-24', 'lastUpdatePostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait Analysis', 'timeFrame': '6 months after vertebrectomy', 'description': 'Measure and correlate geometric and kinematic parameters of the trunk and spine through instrumental motion analysis, before and after vertebrectomy surgery in patients with oncological spinal diseases.'}], 'secondaryOutcomes': [{'measure': 'questionnaire', 'timeFrame': '6 months after vertebrectomy', 'description': 'Evaluate patient-reported functional outcomes through self-administered questionnaires: Oswestry Disability Index and Fall Efficacy Scale-International'}, {'measure': 'spino-pelvic parameters', 'timeFrame': '6 months after vertebrectomy', 'description': 'Measure the geometric spino-pelvic parameters (static) and compare them with the kinematic parameters (dynamic)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vertebrectomy', 'gait analysis'], 'conditions': ['Spine Tumor', 'Vertebral Metastasis', 'Vertebral Column Mass']}, 'descriptionModule': {'briefSummary': 'Analyze the geometric and kinematic parameters of the spine in patients undergoing vertebrectomy through gait analysis, both during the execution of motor tasks such as walking, standing, and basic trunk movements, with the aim of improving the assessment and, therefore, possibly, the treatment and the final clinical outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '18 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with vertebral tumors undergoing vertebrectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Presence of spinal cancer with surgical indication for vertebrectomy\n* Approval and signature of informed consent for the study\n* Ability to undergo movement analysis before the surgery and the 6-month follow-up\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Presence of degenerative, traumatic, or infectious pathologies or spinal deformities\n* Absence of a signed informed consent form\n* Inability to undergo movement analysis before the surgery or the 6-month follow-up'}, 'identificationModule': {'nctId': 'NCT07326969', 'briefTitle': 'MOVEMENT ANALYSIS IN PATIENTS UNDERGOING VERTEBRECTOMIES FOR SPINE ONCOLOGY: A PILOT STUDY', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'MOVEMENT ANALYSIS IN PATIENTS UNDERGOING VERTEBRECTOMIES FOR THE TREATMENT OF SPINE ONCOLOGY: A PILOT STUDY', 'orgStudyIdInfo': {'id': 'GAV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'vertebrectomy', 'description': 'patients with vertebral tumors undergoing vertebrectomy', 'interventionNames': ['Other: vertebrectomy']}], 'interventions': [{'name': 'vertebrectomy', 'type': 'OTHER', 'description': 'en bloc resection of oncological vertebra', 'armGroupLabels': ['vertebrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}