Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT05584020
Status:
RECRUITING
Last Update Posted:
2022-10-18
First Post:
2022-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 330}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-16', 'studyFirstSubmitDate': '2022-10-13', 'studyFirstSubmitQcDate': '2022-10-16', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IKDC score', 'timeFrame': '1 year', 'description': 'The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).\n\nEfficiency of 1 year after operation=Sum of Items/Maximum Possible Score \\*100'}], 'secondaryOutcomes': [{'measure': 'IKDC score', 'timeFrame': '3 months', 'description': 'The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).\n\nEfficiency of 3 months after operation=Sum of Items/Maximum Possible Score \\*100'}, {'measure': 'IKDC score', 'timeFrame': '6 months', 'description': 'The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).\n\nEfficiency of 6 months after operation=Sum of Items/Maximum Possible Score \\*100'}, {'measure': 'IKDC score', 'timeFrame': '2 years', 'description': 'The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).\n\nEfficiency of 2 years after operation=Sum of Items/Maximum Possible Score \\*100'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Injuries']}, 'descriptionModule': {'briefSummary': 'Background: Arthroscopic anterior cruciate ligament(ACL) reconstruction is so far the gold standard for the treatment of ACL ruptures, but this technique still suffers from problems of tendon-bone healing, bone tunnel enlargement, bone resorption, a low rate of return to motion,etc. In recent years, due to the innovation of medical materials and surgical techniques, anterior cruciate ligament repair technology has returned to the field of vision of clinical doctors. This technique has the advantages of preserving the natural ligaments and their proprioceptive sensation, avoiding the bone injury of the tunnel and the complications of the donor site. However, there is still a lack of high-quality clinical randomized controlled trails to provide evidence of the effect of arthroscopic ACL repair.\n\nHypothesis: Arthroscopic ACL repair is comparable to ACL reconstruction in patients with ACL tears (Sherman grades I and II).\n\nStudy Design: This study was a prospective, multicenter, randomized, double-blinded, parallel-controlled, non-inferiority trial design. A total of 330 patients with ACL tears were randomly divided into 2 groups, and were randomly assigned to the experimental group (arthroscopic anterior cruciate ligament repair) and the control group (arthroscopic anterior cruciate ligament reconstruction) according to 1:1. Follow-up knee function and other scores were performed at 3 months, 6 months, 1 year, and 2 years after surgery, and the total study time is expected to be 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with anterior cruciate ligament tear clearly identified by imaging or intraoperative microscope, Sherman grade I, II; planned surgery within 3 weeks after injury\n2. Basic reading and writing skills, and barrier-free communication\n3. A smartphone, can use WeChat or be able to learn\n4. Patients give informed consent, and sign the informed consent form, and the process must meet the requirements of GCP\n\nExclusion Criteria:\n\n1. Combined with other knee joint injuries (posterior cruciate ligament injury, patellar dislocation, osteoarthritis, etc.)\n2. Suffering from systemic immune diseases;\n3. Existing other knee joint diseases or inflammatory diseases, including osteoarthritis, cervical spine disease, rheumatoid arthritis, fibromyalgia, polymyalgia rheumatica, etc.\n4. Patients who have received local hormone injection within 3 months;\n5. Those who have participated in clinical trials or are undergoing other clinical trials within 3 months before screening\n6. Those who have serious primary cardiovascular disease, lung disease, endocrine and metabolic disease or serious diseases that affect their survival, such as tumor or AIDS, the researchers believe that they are not suitable for selection\n7. Patients with severe liver disease, kidney disease, and hematological disease, such as renal function exceeding the upper limit of the normal value, and liver function exceeding 2 times the upper limit of the normal value;\n8. Suffering from viral hepatitis, infectious diseases, severe abnormal blood coagulation mechanism and other Diseases that the researchers consider inappropriate for surgery\n9. Women who are pregnant or breastfeeding, or who plan to become pregnant during the follow-up period, those who have a positive urine human chorionic gonadotropin test result before sampling; menstruating women should wait until the end of menstruation before surgery;\n10. Severe neurological and mental disorders Disease patients;\n11. Suspected or actual history of alcohol and drug abuse.'}, 'identificationModule': {'nctId': 'NCT05584020', 'briefTitle': 'Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury: a Multicenter Randomized Controlled Surgical Trial', 'orgStudyIdInfo': {'id': '2022-0804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACL Repair', 'description': 'Patients under surgical anterior cruciate ligament repair', 'interventionNames': ['Procedure: ACL Repair']}, {'type': 'OTHER', 'label': 'ACL Reconstruction', 'description': 'Patients under surgical anterior cruciate ligament reconstruction', 'interventionNames': ['Procedure: ACL Reconstruction']}], 'interventions': [{'name': 'ACL Repair', 'type': 'PROCEDURE', 'description': 'Patients are undergoing arthroscopic anterior cruciate ligament repair. The native ACL is repaired using very strong sutures. This device is used to repair the native ACL and restore knee stability.', 'armGroupLabels': ['ACL Repair']}, {'name': 'ACL Reconstruction', 'type': 'PROCEDURE', 'description': 'Patients are undergoing arthroscopic anterior cruciate ligament reconstruction. The torn ligament is removed and replaced with a band of tissue that usually connects muscle to bone. The graft tendon is taken from another part of your knee or from a deceased donor.', 'armGroupLabels': ['ACL Reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuesong Dai, Doctor', 'role': 'CONTACT', 'phone': '+8613777882818'}], 'facility': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xuesong Dai, Doctor', 'role': 'CONTACT', 'email': 'daixshz@163.com', 'phone': '+8613777882818'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}