Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-01-04 @ 3:36 AM
Study NCT ID:
NCT03026868
Status:
UNKNOWN
Last Update Posted:
2017-12-15
First Post:
2017-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Quadrilateral Surface Plate for Acetabular Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072039', 'term': 'Fracture Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-13', 'studyFirstSubmitDate': '2017-01-12', 'studyFirstSubmitQcDate': '2017-01-18', 'lastUpdatePostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fracture healing time', 'timeFrame': '4 months', 'description': 'fracture line disappeared in the radiograph'}], 'secondaryOutcomes': [{'measure': 'complication', 'timeFrame': '1 month', 'description': 'wound infection, iatrogenic injury of vessels and nerves, nonunion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acetabular', 'quadrilateral surface plate'], 'conditions': ['Fracture Dislocation']}, 'descriptionModule': {'briefSummary': 'The novel plate could be used to manage acetabular fractures involving quadrilateral surface and posterior column, which may lower the intraoperative blood loss and reduce complication rate.', 'detailedDescription': 'Stoppa approach was more minimally invasive than ilioinguinal approach for pelvic and acetabular fractures. Then, Stoppa approach was widely used clinically. For the fragments involving quadrilateral surface, the Kocher-Langenbeck approach was added because the fixation of posterior fragments could not be obtained with reconstruction plate through single Stoppa approach. Novel quadrilateral surface plate was used in this study to examine its fixed role for posterior fragments. Functional outcome and complication were recorded to compare with the results treated with reconstruction plate. If good results were obtained for the patients fixed with quadrilateral surface plate, it was meaningful to popularize the fixed method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years old\n* Fracture involving quadrilateral surface\n* Operation was conducted within 14 days\n* Fixed with quadrilateral surface plate through Stoppa approach\n\nExclusion Criteria:\n\n* Presented with a pathologic acetabular fracture\n* Neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable\n* Refused to participate\n* Follow-up insufficient 12 months'}, 'identificationModule': {'nctId': 'NCT03026868', 'briefTitle': 'Novel Quadrilateral Surface Plate for Acetabular Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University Third Hospital'}, 'officialTitle': 'Randomized Trails of Different Fixations for Acetabular Fracture Involving Quadrilateral Surface', 'orgStudyIdInfo': {'id': 'HZY2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'quadrilateral surface plate', 'description': 'The fragments of the acetabulum were fixed with novel quadrilateral surface plate through Stoppa approach.', 'interventionNames': ['Procedure: quadrilateral surface plate']}], 'interventions': [{'name': 'quadrilateral surface plate', 'type': 'PROCEDURE', 'description': 'Both anterior and posterior approaches were always conducted to manage the fragments of quadrilateral surface. Novel quadrilateral surface plate was used in this study to examine whether the fragments could be fixed through single Stoppa approach.', 'armGroupLabels': ['quadrilateral surface plate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050051', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiyong Hou, M.D', 'role': 'CONTACT', 'email': 'houzhiyong1234@126.com', 'phone': '+8618533112800'}, {'name': 'Ruipeng Zhang, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhiyong Hou', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}], 'centralContacts': [{'name': 'Zhiyong Hou, M.D', 'role': 'CONTACT', 'email': 'houzhiyong1234@126.com', 'phone': '+8618533112800'}], 'overallOfficials': [{'name': 'Ruipeng Zhang, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Third Hospital of Hebei Medical University Department of Orthopaedic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Medical University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}