Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT03502720
Status:
UNKNOWN
Last Update Posted:
2018-04-23
First Post:
2018-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Personalised Percutaneous External 3D Guide for Scaphoid Fixation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-03-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-20', 'studyFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2018-04-11', 'lastUpdatePostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Screw Position', 'timeFrame': '1st day Xray', 'description': 'Correct position of screw inside of the scaphoid'}], 'secondaryOutcomes': [{'measure': 'Surgery time', 'timeFrame': '1st day', 'description': 'time from beginning to completion of surgery'}, {'measure': 'xray exposure', 'timeFrame': '1st day', 'description': 'radiation exposure during surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scaphoid Bone Fracture']}, 'descriptionModule': {'briefSummary': 'The investigators want to analyse the advantages of using a 3D constructed prototype from a previous CT Scan to model an external customised guide por percutaneous Scaphoid fixation.\n\nThe investigators hypothesise that the usage of this device will shorten surgery time, radiation for the surgery team and optimise the percutaneous screw trajectory inside of the scaphoid bone.', 'detailedDescription': 'To carry out this analysis the investigators will recruit 10 patients who present with an acute fracture of the Scaphoid bone type B1 and B2 (Herbert Classification).\n\nA CT Scan will be performed and a 3D exoesqueleton model printed, previously deciding the position of the fixation screw inside of the bone and adding a cannulated sleeve in the volar aspect of the exoesqueleton to insert the initial positional guide wire for surgery.\n\nSurgery time, surgery radiation exposure and screw positioning will be recorded and compared to 10 control patients operated following standard procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an Scaphoid acute fracture that requires surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute scaphoid fracture (Herbert B1 B2)\n\nExclusion Criteria:\n\n* Concomitant fractures'}, 'identificationModule': {'nctId': 'NCT03502720', 'acronym': 'Scaphix', 'briefTitle': 'A Personalised Percutaneous External 3D Guide for Scaphoid Fixation', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Analysis of a Customized Percutaneous External Guidance System for Scaphoid Fracture Fixation Using 3D Printing', 'orgStudyIdInfo': {'id': 'CSPTCOT2018533'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Patients', 'description': 'Data obtained retrospectively from Scaphoid fixation surgeries performed at our center using the standard procedure (no device for guide wire positioning).\n\nThis control group should have registered al parameters and variables to be studied.', 'interventionNames': ['Procedure: Scaphoid fixation using standard procedure']}, {'label': 'Case Patients', 'description': 'Prospective series of ten patients on which the external 3D guide system will be used.', 'interventionNames': ['Device: Scaphoid fixation using 3D device']}], 'interventions': [{'name': 'Scaphoid fixation using 3D device', 'type': 'DEVICE', 'description': 'A headless screw inserted percutaneously from the volar aspect of the scaphoid in a retrograde manner using a customised 3D exoesqueleton guide', 'armGroupLabels': ['Case Patients']}, {'name': 'Scaphoid fixation using standard procedure', 'type': 'PROCEDURE', 'description': 'A headless screw inserted percutaneously from the volar aspect of the scaphoid in a retrograde manner without using the 3D device (standard procedure)', 'armGroupLabels': ['Control Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Francesc Marcano, Doctor', 'role': 'CONTACT', 'email': 'famarcano@tauli.cat', 'phone': '00937231010'}], 'facility': 'Corporación sanitaria Parc Taulí de Sabadell', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'centralContacts': [{'name': 'Francesc A Marcano Fernandez, MD', 'role': 'CONTACT', 'email': 'francescmarcano@gmail.com', 'phone': '(34) 618023575'}], 'overallOfficials': [{'name': 'Francesc A Marcano Fernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital parc tauli Sabadell'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Francesc A. Marcano-Fernández', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}