Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-31 @ 8:36 PM
Study NCT ID:
NCT04707404
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2021-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Cranioplasty With PEEK and Titanium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2021-01-12', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postoperative improvement of GOSE score', 'timeFrame': 'December 2016 to Decemeber 2020', 'description': 'The GOSE score in 6-month follow-up compared with the GOSE score in admission'}, {'measure': 'Postoperative feelings', 'timeFrame': 'May 2017 to Decemeber 2020', 'description': 'The subjective feelings for cranioplasty effect including 5 degrees of satisfaction and the Glasgow Benefit Inventory Score'}], 'primaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'December 2016 to December 2020', 'description': 'Postoperative complications including Incision infection, Subcutaneous infection, Postoperative hematoma, Subcutaneous effusion, New seizure, Implants exposure and Implants removal.'}], 'secondaryOutcomes': [{'measure': 'Postoperative cranial symmetry', 'timeFrame': 'December 2016 to July 2020', 'description': 'The postoperative cranial symmetry derived from the reconstruction of postoperative CT image.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cranioplasty', 'PEEK', 'Titanium', 'Outcomes', 'Complications', 'Subcutaneous effusion'], 'conditions': ['Brain Injuries', 'Hematoma of Head', 'Skull Defect']}, 'descriptionModule': {'briefSummary': 'Decompressive craniectomy is suggested as an effective surgical intervention for patients with high intracranial pressure. Recently, various customized artificial materials are increasingly employed, e.g., titanium and polyetheretherketone (PEEK). The application of PEEK in cranioplasty is increasing, while its comprehensive evaluation in clinical practice is still insufficient, especially when comparing with the effects of titanium implant. We thus designed the study to evaluate the comprehensive effects of the cranioplasty with PEEK vs titanium.', 'detailedDescription': 'Decompressive craniectomy (DC) is suggested as an effective surgical intervention for patients with high intracranial pressure. For the skull defect after DC, cranioplasty could pro-vide protection, aesthetic and even functional improvements. The autologous bone flap (ABF) was once thought to be an optimal autograft for repairing \\[8\\]. While accumulated studies reported ABF related disadvantages. Recently, various customized artificial materials are increasingly employed, e.g., titanium and polyetheretherketone (PEEK).\n\nTitanium is a widely applied metal material for cranioplasty, attribute to its high strength, bio-compatibility and comparatively low material cost. Currently, pre-operative three dimensional (3D) reconstruction of titanium brings a customized implant for optimal shaping effect. However, titanium implant is still confronted with complications of infection, implant exposure, etc.\n\nPEEK is a novel polymer used to rebuild the personalized construction. Through the precise computational reconstruction of high-resolution computed tomography (CT) scanning, the customized PEEK could more accurately rebuild the complex cranial and maxillofacial structure. The application of this material in cranioplasty is increasing, while its comprehensive evaluation in clinical practice is still insufficient, especially when comparing with the effects of titanium implant.\n\nWe thus designed the study to evaluate the comprehensive effects of the cranioplasty with PEEK vs titanium. The data of the patients implanted PEEK or titanium in four years in our institute were retrospectively collected and evaluated, in respects of the general information of patients, postoperative complications, shaping effects, and psychosocial improvements, to display a comprehensive evaluation for these two implants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients received cranioplasty with PEEK and titanium from December 2016 to July 2020 in Renji hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients underwent cranioplasty with PEEK or Titanium.\n* Patients underwent cranioplasty and had complete data and 6-month follow-up records.\n\nExclusion Criteria:\n\n* Patients underwent cranioplasty with other material or ABF.\n* Patients had incomplete data or follow-up records.'}, 'identificationModule': {'nctId': 'NCT04707404', 'briefTitle': 'Comparison of Cranioplasty With PEEK and Titanium', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'COMPREHENSIVE EVALUATION FOR CRANIOPLASTY WITH POLYETHERETHERKETONE AND TITANIUM IMPLANTS', 'orgStudyIdInfo': {'id': 'RJCP2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PEEK', 'description': 'Cranioplasty patients with PEEK.', 'interventionNames': ['Procedure: Cranioplasty']}, {'label': 'Titanium', 'description': 'Cranioplasty patients with titanium mesh.', 'interventionNames': ['Procedure: Cranioplasty']}], 'interventions': [{'name': 'Cranioplasty', 'type': 'PROCEDURE', 'description': 'The surgery implanted artificial material to repair the skull defect.', 'armGroupLabels': ['PEEK', 'Titanium']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Junfeng Feng', 'investigatorAffiliation': 'RenJi Hospital'}}}}