Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT04310956
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2020-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A RCT for Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair
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': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2020-03-13', 'studyFirstSubmitQcDate': '2020-03-13', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement of AOFAS score', 'timeFrame': 'From pre-operation to 6 months postoperative'}], 'secondaryOutcomes': [{'measure': 'improvement of AOFAS score', 'timeFrame': 'From pre-operation to 3 months postoperative'}, {'measure': 'Improvement of VAS score', 'timeFrame': 'From pre-operation to 3 and 6 months postoperative'}, {'measure': 'ligament injury recurrences', 'timeFrame': 'up to 6 months postoperative'}, {'measure': 'secondary surgery', 'timeFrame': 'up to 6 months postoperative'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ligament Injury']}, 'descriptionModule': {'briefSummary': "Purpose of this study is to evaluate the effectiveness and safety of Y-Knot all-suture anchor by comparing patients' clinical outcome after ankle ligaments repair surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female, no less than 18 years old;\n* Patient was diagnosed as Collateral Ligament injury or Achilles tendon injury based on MRI or X-Ray who need to conduct foot\\&ankle repair surgery by investigator;\n* Patient willing to sign a written consent form participating in this study；\n* Subject is able to understand study, willing to comply the study procedures, and willing to return to hospital for follow-up up to 6 months postoperative；\n* Life expectancy is more than 2 years post-operationally;\n\nExclusion Criteria:\n\n* Conducted surgery at index ankle and possibly influence the outcome evaluation;\n* Bilateral ankle surgery;\n* Suffering concurrent ankle disease that may leads to a surgery during the study phase;\n* known or suspected allergies to implant and/or instrument materials;\n* pathological conditions of bone which would adversely affect the anchor fixation; with concurrent severe injury at index leg that may influence the outcome evaluation; Severe obesity;\n* With concurrent disease that may influence the index ankle function;\n* Patients with active sepsis or infection;\n* With concurrent disease that may influence the stability of device and rehabilitation;\n* Immune suppression, impairment of immune function, or autoimmune disease;\n* Pregnant or lactating women;\n* Known noncompliance or lost follow-up risk;\n* Participated other drug, biologic, or device clinical trial 12 months before enrollment;\n* Alcohol or drug abuser;\n* Other inappropriate condition based on investigator determination;'}, 'identificationModule': {'nctId': 'NCT04310956', 'briefTitle': 'A RCT for Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'ConMed Linvatec Beijing'}, 'officialTitle': 'A Multi-center, Randomized Controlled Trial to Evaluate the Effectiveness and Safety of Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair', 'orgStudyIdInfo': {'id': 'P18101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Y-Knot group', 'description': 'Patients use Y-Knot all-suture anchor', 'interventionNames': ['Device: Y-Knot all-suture anchor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biocomposite suture anchor', 'description': 'Patients use Biocomposite suture anchor', 'interventionNames': ['Device: Biocomposite suture anchor']}], 'interventions': [{'name': 'Y-Knot all-suture anchor', 'type': 'DEVICE', 'description': 'Y-knot all-suture anchor will be implanted to participants', 'armGroupLabels': ['Y-Knot group']}, {'name': 'Biocomposite suture anchor', 'type': 'DEVICE', 'description': 'Biocomposite suture anchor will be implanted to participants', 'armGroupLabels': ['Biocomposite suture anchor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hosptial', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Chengdu', 'country': 'China', 'facility': 'Sichuan Orthopedics Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Jinan', 'country': 'China', 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Shenzhen', 'country': 'China', 'facility': "Shenzhen Second People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ConMed Linvatec Beijing', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}