Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT04711720
Status:
UNKNOWN
Last Update Posted:
2021-01-29
First Post:
2021-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial for Patients Underwent Total Hip Arthroplasties Assisted by Surgical Navigation System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acetabular location accuracy', 'timeFrame': 'Within 1 week after surgery', 'description': 'Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area'}], 'secondaryOutcomes': [{'measure': 'Operation time', 'timeFrame': 'Immediately after surgery', 'description': 'Time from skin incision to wound closure'}, {'measure': 'the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': '6 months after surgery', 'description': "The WOMAC is a self administered questionnaire to assess joint function and quality of life for patients with osteoarthritis; it consists of 24 items: pain (5 items), stiffness (2 items), and physical function (17 items). The higher the total score, the worse the patient's pain, stiffness, and functional limitations. The WOMAC is validated for various languages, including Chinese"}, {'measure': 'Harris Hip Score (HHS)', 'timeFrame': '6 months after surgery', 'description': 'a rating scale with a maximum of 100 points, including the domains of pain, function, deformity, and motion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Arthropathy']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled, multicenter study. According to the inclusion criteria, volunteers were recruited from patients undergoing total hip arthroplasty. After signing the informed consent, the subjects were assigned to the experimental group and the control group through the central randomization system. The researchers will complete the total hip arthroplasty for patients in the experimental group with the assistance of surgical navigation system. The patients in the control group do not use the surgical navigation system. The proportion of acetabular abduction angle and anteversion angle in the lewinnek safe area is the primary outcome measurement. The operation time, WOMAC score, Harris score, range of motion and dislocation rate are the secondaryoutcome measurements. The incidence of complications, devices and other adverse events were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of primary hip osteoarthritis(OA), fracture of femoral neck (FFN),or secondary hip osteoarthritis due to developmental dysplasia of the hip (DDH), hip avascular necrosis (AVN), rheumatoid arthritis (RA), ankylosing spondylitis (AS), and coxa plana\n\nExclusion Criteria:\n\nSevere vascular diseases of the lower extremity Neuromuscular diseases Infectious diseases Severe dysfunctions of major organs Severe neurosensory deficiencies caused by spinal diseases Unable to receive CT/MRI scans'}, 'identificationModule': {'nctId': 'NCT04711720', 'briefTitle': 'A Randomized Controlled Trial for Patients Underwent Total Hip Arthroplasties Assisted by Surgical Navigation System', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS"Surgical Navigation System', 'orgStudyIdInfo': {'id': 'VTSTH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Navigation', 'interventionNames': ['Device: "VTS" surgical navigation system']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': '"VTS" surgical navigation system', 'type': 'DEVICE', 'description': 'The"VTS" surgical navigation system can accurately match the preoperative and intraoperative image data with the patient\'s anatomical structure on the operating table, track the surgical instruments during the operation, and update the position of the surgical instruments on the patient\'s image in real time, so that the doctor can clearly understand the position of the surgical instruments relative to the patient\'s anatomical structure, and make the operation procedure more accurate and safer.', 'armGroupLabels': ['Navigation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Huan Tian, MD PhD', 'role': 'CONTACT', 'email': 'tianhua@bjmu.edu.cn', 'phone': '+8613511065187'}, {'name': 'Xiao Geng, MD', 'role': 'CONTACT', 'email': 'gengxiao@bjmu.edu.cn', 'phone': '+8618811332096'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, {'name': 'Chifeng Municipal Hospital', 'class': 'OTHER'}, {'name': 'Jining Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}