Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-03-20 @ 12:43 PM
Study NCT ID:
NCT05871866
Status:
UNKNOWN
Last Update Posted:
2023-05-23
First Post:
2023-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-15', 'studyFirstSubmitDate': '2023-05-15', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'advantages using INFIX', 'timeFrame': '6 months', 'description': 'good patient tolerance'}, {'measure': 'union', 'timeFrame': '1 yea', 'description': 'radiological'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unstable Pelvic Fractures']}, 'referencesModule': {'references': [{'pmid': '31250805', 'type': 'BACKGROUND', 'citation': 'Steer R, Balendra G, Matthews J, Wullschleger M, Reidy J. The use of anterior subcutaneous internal fixation (INFIX) for treatment of pelvic ring injuries in major trauma patients, complications and outcomes. SICOT J. 2019;5:22. doi: 10.1051/sicotj/2019019. Epub 2019 Jun 28.'}, {'pmid': '30095676', 'type': 'BACKGROUND', 'citation': 'Lee C, Sciadini M. The Use of External Fixation for the Management of the Unstable Anterior Pelvic Ring. J Orthop Trauma. 2018 Sep;32 Suppl 6:S14-S17. doi: 10.1097/BOT.0000000000001251.'}, {'pmid': '27825365', 'type': 'BACKGROUND', 'citation': 'Hoskins W, Bucknill A, Wong J, Britton E, Judson R, Gumm K, Santos R, Sheehy R, Griffin X. A prospective case series for a minimally invasive internal fixation device for anterior pelvic ring fractures. J Orthop Surg Res. 2016 Nov 8;11(1):135. doi: 10.1186/s13018-016-0468-9.'}, {'pmid': '23995332', 'type': 'BACKGROUND', 'citation': 'Muller FJ, Stosiek W, Zellner M, Neugebauer R, Fuchtmeier B. The anterior subcutaneous internal fixator (ASIF) for unstable pelvic ring fractures: clinical and radiological mid-term results. Int Orthop. 2013 Nov;37(11):2239-45. doi: 10.1007/s00264-013-2032-0. Epub 2013 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'Pelvic fractures are common presentations to major trauma centers and are associated with significant morbidity in polytrauma patients. Traditional open reduction and internal fixation is associated with a high incidence of surgical morbidity, while external fixators, used for both temporary stabilisation and as definitive management, have a complication rate of up to 62% \\[4\\], with poor patient tolerance, pin site infection and aseptic loosening the more commonly documented complications in the literature.\n\nMinimally invasive techniques have become more popular recently in the management of pelvic injuries due to their lower incidence of surgical morbidity. The application of a pelvic internal fixator (INFIX) has been presented as a comparable alternative to external fixation of anterior pelvic ring injuries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had APC-II\n* Patients who had APC-III\n* Patients who had LC - II\n* Patients who had LC -III\n\nExclusion Criteria:\n\n* Patients who had immature skeletons or medical contraindications such as combined neurovascular injuries and uncontrolled medical diseases.\n* Open fractures.\n* Stable pelvic ring fractures.\n* Patients who had combined acetabular fractures\n* Patients who had a hernia or previous lower abdominal surgery.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT05871866', 'briefTitle': 'The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures', 'orgStudyIdInfo': {'id': 'soh-Med-23-04-01MD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'minimally invasive internal fixation device "infix"', 'type': 'PROCEDURE', 'description': 'An INFIX involves the insertion of spinal pedicle screws in the anterior pelvis (supra-acetabular entry) and the placement of a connecting rod in the subcutaneous tissue of the patient'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'magdy m Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'mohamed E Ahmed, assistant lecteure', 'role': 'CONTACT', 'email': 'mohamed.essam@med.sohag.edu.eg', 'phone': '01007422680'}, {'name': 'Elshazly s Mousa, professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Mohamed Essam Ahmed', 'investigatorAffiliation': 'Sohag University'}}}}