Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 5:49 PM
Study NCT ID:
NCT06856356
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2024-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065287', 'term': 'Robotic Surgical Procedures'}], 'ancestors': [{'id': 'D025321', 'term': 'Surgery, Computer-Assisted'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D012371', 'term': 'Robotics'}, {'id': 'D001331', 'term': 'Automation'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors are independent of the intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2025-02-26', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'mLDFA', 'timeFrame': 'preoperative Day 1-3, postoperative Day 1-3', 'description': 'the lateral angle between the mechanical axis of the femur and the tangent of the distal end of the femoral prosthesis. The target value is 90°. \\>90° is varus, and \\<90° is valgus. Varus or valgus exceeding 3° is defined as femoral prosthesis position deviation.'}, {'measure': 'mMPTA', 'timeFrame': 'preoperative Day 1-3, postoperative Day 1-3', 'description': 'medial angle between the mechanical axis of the tibia and the tangent of the tibial prosthesis, the target value is 90°, \\<90° is varus, \\>90° is valgus, and valgus exceeding 3° is defined as tibial prosthesis position deviation'}, {'measure': 'Femoral prosthesis flexion angle (α angle)', 'timeFrame': 'preoperative Day 1-3, postoperative Day 1-3', 'description': 'on the standard lateral knee X-ray, the angle between the anatomical axis of the distal femur and the vertical line of the distal femoral prosthesis'}, {'measure': 'Tibial posterior tilt angle (β angle):', 'timeFrame': 'preoperative Day 1-3, postoperative Day 1-3', 'description': 'on the standard lateral knee X-ray, the angle between the anatomical axis of the tibia and the lower surface of the tibial prosthesis.'}], 'primaryOutcomes': [{'measure': 'Postoperative patient satisfaction', 'timeFrame': 'Month 1, Month 3, Month 6, Month 12, Month 24', 'description': "Use a questionnaire to investigate patients' satisfaction with their knee joint after surgery"}, {'measure': 'Forgotten Joint Scores', 'timeFrame': 'Month 1, Month 3, Month 6, Month 12, Month 24', 'description': 'The Forgotten Joint Score (FJS) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total knee arthroplasty.The total score is 100 points. The higher the score, the better the degree of forgetfulness of the artificial joint.'}, {'measure': 'WOMAC score', 'timeFrame': 'Month 1, Month 3, Month 6, Month 12, Month 24', 'description': 'Use WOMAC scoring scale to assess the condition of the knee joint. The WOMAC score consists of 24 items with a total score of 100. The higher the score, the more severe the limitation of joint function.'}, {'measure': 'Knee Society Score', 'timeFrame': 'Month 1, Month 3, Month 6, Month 12, Month 24', 'description': "The KSS score was assessed using the American Knee Society scoring criteria.The full score is 100 points. The higher the score, the better the patient's knee function."}], 'secondaryOutcomes': [{'measure': 'SF-12', 'timeFrame': 'Month 1, Month 3, Month 6, Month 12, Month 24', 'description': 'The health status of patients was assessed using the SF-12 health-related quality of life scale. The higher the score, the better the quality of life.'}, {'measure': 'visual analogue scale score', 'timeFrame': 'Month 1, Month 3, Month 6, Month 12, Month 24', 'description': 'Visual analogue scale (VAS) for pain assessment。0 means no pain, 10 means the most painful, the higher the value, the higher the pain level of the patient'}, {'measure': 'Range of motion', 'timeFrame': 'Month 1, Month 3, Month 6, Month 12, Month 24', 'description': "Physical examination to assess the knee's range of motion"}, {'measure': 'Hip-knee-ankle angle', 'timeFrame': 'postoperative Day 1-3', 'description': 'Measuring Hip-knee-ankle angle in radiology'}, {'measure': 'Complication', 'timeFrame': 'Month 1, Month 3, Month 6, Month 12, Month 24', 'description': "Record the patient's postoperative complications. For example, Persistent pain, fracture, superficial local infection, infection, thromboembolism."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total knee arthroplasty', 'robot-assisted', 'alignment', 'satisfication', 'complication'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to understand the application value of the Orthopedic Joint Surgery Navigation System in assisting surgeons to accurately place prosthetic components in adult knee replacement surgery. It will also confirm its effectiveness and safety in clinical application.', 'detailedDescription': 'The purpose of this clinical trial is to understand the application value of the Orthopedic Joint Surgery Navigation System in assisting surgeons to accurately place prosthetic components in adult knee replacement surgery. It will also confirm its effectiveness and safety in clinical application. The main questions it aims to answer are:\n\nDoes the Orthopedic Joint Surgery Navigation System improve the accuracy of prosthetic component placement in knee replacement surgery? Is the Orthopedic Joint Surgery Navigation System superior to traditional total knee replacement What medical problems do participants encounter when taking medication ABC? Researchers will compare the Orthopedic Joint Surgery Navigation System with traditional total knee replacement surgery (using a "four-in-one" osteotomy guide) to see if the Orthopedic Joint Surgery Navigation System is superior to traditional total knee replacement in terms of prosthesis three-dimensional position, force alignment, patient satisfaction, functional scores, complications, etc.\n\nParticipants will:\n\nEnd-stage knee osteoarthritis patients receive total knee replacement with the Orthopedic Joint Surgery Navigation System or traditional total knee replacement surgery Visit the clinic for examination and testing every 3 months Record their imaging data, satisfaction, functional scores, complications, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects voluntarily participate in the trial and sign the informed consent form;\n2. Aged 18 to 80 years old (inclusive), regardless of gender;\n3. Patients who need total knee replacement surgery;\n4. Those who can communicate well with the researchers and comply with the trial requirements.\n\nExclusion Criteria:\n\n1. Patients who are allergic to the drugs used in this trial or the implant materials;\n2. Patients with immature bone development;\n3. Patients with active infection;\n4. Patients with neuropathy of the knee joint;\n5. Patients with poor bone quality that is not conducive to prosthesis fixation;\n6. Patients with general conditions or concomitant diseases that make it difficult for people to tolerate surgery;\n7. Patients with insufficient quadriceps muscle strength;\n8. Patients with insufficient skin coverage near the surgical site and intolerance to surgery;\n9. Patients with severe femoral or tibial deformities and other severe deformities outside the joint;\n10. Patients with metal implants in the joint surgical area that affect the execution of the surgical plan;\n11. Pregnant or lactating women;\n12. Patients with severe epilepsy or mental illness;\n13. Patients with alcohol dependence or drug addiction;\n14. Patients with severe coagulation disorders;\n15. Patients who have participated in or are participating in other clinical trials within one month of enrollment;\n16. Patients who are considered by the researchers to be unsuitable for participating in this clinical trial for other reasons. Those who meet any of the above exclusion criteria need to be excluded.'}, 'identificationModule': {'nctId': 'NCT06856356', 'briefTitle': 'Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of University of Science and Technology of China'}, 'officialTitle': 'Comparison of Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty and Conventional Total Knee Arthroplasty: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'XJS2023-1-18(WK)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robot-assisted total knee arthroplasty', 'description': 'Using an orthopedic joint surgery navigation system to assist total knee replacement', 'interventionNames': ['Procedure: Robot-assisted surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional total knee arthroplasty', 'description': 'Using a conventional 4-in-1 osteotomy guide for total knee replacement', 'interventionNames': ['Procedure: Conventional total knee arthroplasty']}], 'interventions': [{'name': 'Robot-assisted surgery', 'type': 'PROCEDURE', 'description': 'Orthopedic surgeons perform total knee arthroplasty using an orthopedic joint surgery navigation system', 'armGroupLabels': ['Robot-assisted total knee arthroplasty']}, {'name': 'Conventional total knee arthroplasty', 'type': 'PROCEDURE', 'description': 'Orthopedic surgeons perform total knee arthroplasty using a 4 in 1 osteotomy guide', 'armGroupLabels': ['Conventional total knee arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Zhu, M.D', 'role': 'CONTACT'}], 'facility': 'the first affiliated hospital of USTC', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'Xianzuo Zhang, Ph.D', 'role': 'CONTACT', 'email': 'zhangxianzuo@foxmail.com', 'phone': '+8618556533086'}, {'name': 'Xianyue Shen, M.D', 'role': 'CONTACT', 'email': 'shenxianyue0616@163.com', 'phone': '17843122928'}], 'overallOfficials': [{'name': 'Chen Zhu, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of USTC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of University of Science and Technology of China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}