Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-02-11 @ 11:23 AM
Study NCT ID:
NCT05119595
Status:
COMPLETED
Last Update Posted:
2025-05-13
First Post:
2021-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012887', 'term': 'Skull Fractures'}], 'ancestors': [{'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'studies@aesculap.de', 'phone': '0049746195', 'title': 'Diana Kupferschmid, Study Manager of B. Braun', 'phoneExt': '0', 'organization': 'B.Braun Aesculap'}, 'certainAgreement': {'otherDetails': 'The clinic will ensure that a manuscript intended for publication that is related to this study is made available to the sponsor for review before submission in order to give the sponsor the opportunity to comment. Furthermore, the clinic ensures that an abstract intended for presentation, as well as a manuscript intended for this purpose and the presentation slides themselves, are sent to the sponsor before submission to a congress.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 ± 2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Observational Study Group', 'description': 'In total, 3 adverse events were reported in 3 study patients. Two of the three AEs were classified as serious adverse events.\n\nIn 2 of the AEs a measure was taken which included non-operative measures (n = 1) and reoperation (n = 1), in 1 of the AE no therapeutic measure due to the AE was taken (n=1). No causal relationship to the investigational device was stated in any of the cases. Consequently, none of the AE is related to be an ADE (Adverse Device Effect).', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 1, 'seriousNumAtRisk': 25, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Epidural collection of liquid and air in access area, non-space-consuming.Clinically inapparent.', 'notes': 'Extension of epidural space might be caused by large defect of brain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Intracerebral hemorrhage after resection with generalized seizure and hemiparesis on the right side.', 'notes': 'Probably the hemorrhage was caused by occlusion of the draining veine.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intracerebral hemorrhage after resection', 'notes': 'Probably the bleeding was caused by the tumor resection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Planarity of Bone Flap After Implantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Study Group', 'description': "All patients that were included in the study received treatment with the investigational device according to site's clinical routine."}], 'classes': [{'title': 'at discharge (about up to 2 weeks after surgery)', 'categories': [{'title': 'yes', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'no', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'could not be evaluated', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'post-operative follow-up (3±2 months after surgery)', 'categories': [{'title': 'yes', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'no', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'could not be evaluated', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through postoperative course: at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months after surgery)', 'description': 'The primary variable was the planarity of the bone flap after implantation. The bone flap planarity was evaluated as the rate of patients in which a dislocation of the bone flap occurred - defined as the height of the tilting (depression / protrusion) greater than the bone width.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (Intra- and Postoperative)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Study Group', 'description': "All patients that were included in the study received treatment with the investigational device according to site's clinical routine."}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Number of adverse events e.g. foreign body reactions, infections, injury to the dura, injury to the scalp, epiduralhaematoma, wound healing disorders with special focus on (serious) adverse events with (possible) relation to the investigational product', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Study Group', 'description': "All patients that were included in the study received treatment with the investigational device according to site's clinical routine."}], 'classes': [{'title': 'very good', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'acceptable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'very poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'intraoperative', 'description': 'Assessment of handling, documented on a Likert scale 1 to 5 (1 is the very good, 2 is good, 3 is acceptable, 4 is poor, 5 is very poor)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stability of the Bone Flap After Fixation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Study Group', 'description': "All patients that were included in the study received treatment with the investigational device according to site's clinical routine."}], 'classes': [{'title': 'surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'very good', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'good', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'acceptable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'could not be evaluated', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'at discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'title': 'very good', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'good', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'acceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'could not be evaluated', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'at follow up (3±2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'very good', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'good', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'acceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'could not be evaluated', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months)', 'description': 'Assessment of stability of the bone flap, documented on a Likert scale 1 to 5 (1≙very good, 2≙good, 3≙medium, 4≙poor, 5≙very poor)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One of 25 patients died after surgery before discharge, 7 patients were lost to follow-up between discharge and follow up visit.'}, {'type': 'SECONDARY', 'title': 'Cosmetic Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Study Group', 'description': "All patients that were included in the study received treatment with the investigational device according to site's clinical routine."}], 'classes': [{'title': 'Cosmetic outcome by surgeon (surgery)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'good', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'fair', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'could not be evaluated', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cosmetic outcome by surgeon (discharge)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'title': 'good', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'fair', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'could not be evaluated', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cosmetic outcome by surgeon (follow up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'good', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'fair', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'could not be evaluated', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cosmetic outcome by patient (discharge)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'title': 'good', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'fair', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'could not be evaluated', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cosmetic outcome by patient (follow up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'good', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'fair', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'could not be evaluated', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months)', 'description': 'Assessment of cosmetic outcome intraoperatively, at discharge and at post-operative follow-up documented on a 3 point scale (good, fair, bad)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At the discharge visit, in 2 cases no evaluation of the cosmetic outcome by the surgeon was available because in one case no MRI scan was conducted and in another case the patient died after surgery before discharge.\n\nAt the follow-up visit, in 8 cases, no evaluation of the cosmetic outcome was available because the follow-up visit did not take place.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Observational Study Group', 'description': "All patients that were included in the study received treatment with the investigational device according to site's clinical routine."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Due to a small defect size, only 2 clamps were used in 64% of cases. In 2 cases (8%), no indication was given as to how many CranioFix®2 clamps were used.', 'achievements': [{'groupId': 'FG000', 'numUnits': '53', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '33', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '20', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'typeUnitsAnalyzed': 'CranioFix®2'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Observational Study Group', 'description': "All patients that were included in the study received treatment with the investigational device according to site's clinical routine."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53', 'spread': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-24', 'size': 195675, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-24T05:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2021-10-07', 'resultsFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2021-11-02', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-12', 'studyFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Planarity of Bone Flap After Implantation', 'timeFrame': 'Through postoperative course: at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months after surgery)', 'description': 'The primary variable was the planarity of the bone flap after implantation. The bone flap planarity was evaluated as the rate of patients in which a dislocation of the bone flap occurred - defined as the height of the tilting (depression / protrusion) greater than the bone width.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (Intra- and Postoperative)', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Number of adverse events e.g. foreign body reactions, infections, injury to the dura, injury to the scalp, epiduralhaematoma, wound healing disorders with special focus on (serious) adverse events with (possible) relation to the investigational product'}, {'measure': 'Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale', 'timeFrame': 'intraoperative', 'description': 'Assessment of handling, documented on a Likert scale 1 to 5 (1 is the very good, 2 is good, 3 is acceptable, 4 is poor, 5 is very poor)'}, {'measure': 'Stability of the Bone Flap After Fixation', 'timeFrame': 'intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months)', 'description': 'Assessment of stability of the bone flap, documented on a Likert scale 1 to 5 (1≙very good, 2≙good, 3≙medium, 4≙poor, 5≙very poor)'}, {'measure': 'Cosmetic Outcome', 'timeFrame': 'intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months)', 'description': 'Assessment of cosmetic outcome intraoperatively, at discharge and at post-operative follow-up documented on a 3 point scale (good, fair, bad)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bone Flap Fixation', 'Fractures to the Neurocranium', 'Craniotomized bone flaps'], 'conditions': ['Skull Fractures']}, 'descriptionModule': {'briefSummary': 'The CranioFix®2 PMCF study has been set up as an action within the framework of a proactive post-market surveillance system of the manufacturer. The aim of this observational study is to collect systematically and proactively data regarding the performance of CranioFix®2, like adverse events (AEs), handling and cosmetic outcome, under daily clinical practice when used as intended by the manufacturer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients enrolled will be prospectively examined according to the study plan until follow-up examination (depending on routine in clinic).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Age ≥ 18 years\n* Use of CranioFix®2 system according to IfU\n* Planned postoperative MRI within clinical routine\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients with hypersensitivity to metals or allergies to the implant materials\n* Inflammations in the region of the implant site\n* Bone conditions that rule out the application of CranioFix®2 titanium clamps\n* Use with artificial cranial bone flaps\n* Bone tumors in the area supporting the implant\n* Degenerative bone diseases\n* Missing dura mater\n* Application in the facial skull (viscerocranium) and in the orbital or skull-base region\n* Combination of implant components from different manufacturers, i.e. additional use of plates and screws on the same bone fragment'}, 'identificationModule': {'nctId': 'NCT05119595', 'acronym': 'CRANFLAP', 'briefTitle': 'PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Prospective, Single Center PMCF-study on the Performance and Safety of the CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures to the Neurocranium', 'orgStudyIdInfo': {'id': 'AAG-O-H-2043'}}, 'contactsLocationsModule': {'locations': [{'zip': '70174', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Klinikum Stuttgart - Katharinenhospital', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}