Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-31 @ 11:01 PM
Study NCT ID:
NCT05947734
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2023-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robot Assisted Total Hip Arthroplasties
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': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-15', 'studyFirstSubmitDate': '2023-07-09', 'studyFirstSubmitQcDate': '2023-07-09', 'lastUpdatePostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, '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'}, {'measure': '36-Item Short Form Survey (SF-36）', 'timeFrame': '6 months after surgery', 'description': "The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being."}, {'measure': 'dislocation rate of hip joint', 'timeFrame': '6 months after surgery', 'description': 'the proportion of participants encountered with dislocation of hip joint after THA'}, {'measure': 'adverse events or complications', 'timeFrame': '6 months after surgery', 'description': 'the rate of adverse events or complications in all the participants'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Arthropathy']}, 'referencesModule': {'references': [{'pmid': '39420701', 'type': 'DERIVED', 'citation': 'Geng X, Dong Z, Li Y, Zhao M, Liu Y, Li Z, Cai H, Zhang M, Yan X, Sun Z, Lv X, Guo F, Li F, Tian H. Precise Acetabular Prosthesis Positioning Using a Novel Robot-Assisted Total Hip Arthroplasty System: A Multicenter, Randomized Controlled Trial. Orthop Surg. 2025 Jan;17(1):141-150. doi: 10.1111/os.14277. Epub 2024 Oct 17.'}]}, '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 robotic system. The patients in the control group do not use the surgical robotic 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, SF-36 and dislocation rate are the secondary outcome 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\n* Clinical 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\n* Severe 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': 'NCT05947734', 'briefTitle': 'Robot Assisted Total Hip Arthroplasties', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS" Surgical Robotic System', 'orgStudyIdInfo': {'id': 'VTSTHrobot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'robotic', 'interventionNames': ['Device: "VTS" surgical robotic system']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': '"VTS" surgical robotic system', 'type': 'DEVICE', 'description': 'The"VTS" surgical robotic system can accurately match the preoperative and intraoperative image data with the patient\'s anatomical structure on the operating table, track and locate the surgical instruments during the operation. With the help of the robotic arm, the surgeon can make the operation procedure more accurate and safer.', 'armGroupLabels': ['robotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100181', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, {'name': 'Chifeng Municipal Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}