Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:28 AM
Study NCT ID:
NCT07382050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-02
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Multicenter Clinical Study on the Efficacy and Safety of the Zirconia Ceramic Hip Joint Prosthesis System After Its Market Launch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 290}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-25', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-01-25', 'lastUpdatePostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Harris score', 'timeFrame': 'Six months', 'description': 'The patient returned to the outpatient department for a follow-up visit, and the scale was followed up'}], 'secondaryOutcomes': [{'measure': 'FJS score', 'timeFrame': 'Six months', 'description': 'The patient returned to the outpatient department for a follow-up visit, and the scale was followed up'}, {'measure': 'operation time', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Measure the time from the moment the knife touches the skin to the completion of the surgical incision suture'}, {'measure': 'WOMAC', 'timeFrame': 'Six months', 'description': 'he patient returned to the outpatient department for a follow-up visit, and the scale was followed up'}, {'measure': 'AE/SAE and postoperative complications', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Describe the number and frequency of various adverse events, adverse events related to the study product, adverse events leading to dropout, and serious adverse events. Describe the number and frequency of various complications and complications related to the study product. Provide corresponding lists for adverse events and complications. Calculate the survival rate of the prosthesis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total hip arthroplasty', 'Zirconia ceramic prosthesis', 'efficacy', 'safety'], 'conditions': ['THA', 'Prosthesis']}, 'descriptionModule': {'briefSummary': 'This study adopted a prospective, multi-center, single-group target value trial design to evaluate the safety and efficacy of the hip joint prosthesis system produced by Beijing Anshou Technology Co., Ltd. in total hip arthroplasty. This clinical study selected seven clinical centers and recruited 290 subjects. Each center competed for enrollment, with the requirement that each center should undertake no less than 8 cases and no more than half of the total cases. The enrollment stopped when the total number of cases met the design requirements. After the patients signed the informed consent form, they entered the screening process. After the screening was successful, the hip joint prosthesis system produced by Beijing Anshou Technology Co., Ltd. was implanted, and follow-up was conducted for the patients at "before surgery, on the day of surgery, immediately after surgery until discharge, 2 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery." The demographic information and various evaluation indicators of the subjects were collected.', 'detailedDescription': 'This study adopted a prospective, multi-center, single-group target value trial design to evaluate the safety and efficacy of the hip joint prosthesis system produced by Beijing Anshou Technology Co., Ltd. in total hip arthroplasty. This clinical study selected seven clinical centers and recruited 290 subjects. Each center competed for enrollment, with the requirement that each center should undertake no less than 8 cases and no more than half of the total cases. The enrollment stopped when the total number of cases met the design requirements. After the patients signed the informed consent form, they entered the screening process. After the screening was successful, the hip joint prosthesis system produced by Beijing Anshou Technology Co., Ltd. was implanted, and follow-up was conducted for the patients at "before surgery, on the day of surgery, immediately after surgery until discharge, 2 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery." The demographic information and various evaluation indicators of the subjects were collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "1. The patient's age ranges from 18 to 80 years old (inclusive), with no gender restrictions.\n2. The patient's bones have matured.\n3. The patient is indicated for hip replacement surgery\n4. The subjects participating in the study were undergoing hip replacement for the first time\n5. The subject or his/her guardian is willing and able to sign the informed consent form", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The patient's age ranges from 18 to 80 years old (inclusive), with no gender restrictions.\n2. The patient's bones have matured.\n3. The patient is indicated for hip replacement surgery\n4. The subjects participating in the study were undergoing hip replacement for the first time\n5. The subject or his/her guardian is willing and able to sign the informed consent form\n\nExclusion Criteria:\n\n1. There are contraindications for hip replacement surgery\n2. It is known that the patient has a history of allergy to one or more implant materials\n3. Pregnant or lactating women\n4. Hip dysplasia is classified into CROWE grades 3 and 4\n5. Those who are physically weak or unable to tolerate surgery due to other systemic diseases, as well as those with an expected lifespan of less than two years\n6. The reasons why other researchers believe that patients are not suitable for this study"}, 'identificationModule': {'nctId': 'NCT07382050', 'briefTitle': 'A Prospective Multicenter Clinical Study on the Efficacy and Safety of the Zirconia Ceramic Hip Joint Prosthesis System After Its Market Launch', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'A Prospective Multicenter Clinical Study on the Efficacy and Safety of the Zirconia Ceramic Hip Joint Prosthesis System After Its Market launchM20251018', 'orgStudyIdInfo': {'id': 'M20251018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Received the hip joint prosthesis system implanted by Beijing Anthrone Technology Co., Ltd.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Yuhang Zheng, MD', 'role': 'CONTACT', 'email': 'zhengyuhang0723@126.com', 'phone': '010-18811185091'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will be published in the form of an academic paper.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, {'name': 'Peking University First Hospital', 'class': 'OTHER'}, {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, {'name': 'Peking University Shougang Hospital', 'class': 'OTHER'}, {'name': "Peking University People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}