Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT06897293
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2025-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of MBR + Suture Tape and MBR for CLAI in GJL Cases: A Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007593', 'term': 'Joint Instability'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-03-20', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Signal to noise value of anterior talofibular ligament', 'timeFrame': '6 months post-treatment', 'description': 'Signal to noise value of the anterior talofibular ligament'}, {'measure': 'Signal to noise value of the anterior talofibular ligament', 'timeFrame': '12 months post-treatment', 'description': 'Signal to noise value of the anterior talofibular ligament'}, {'measure': 'Signal to noise value of the anterior talofubular ligament', 'timeFrame': '24 months post-treatment', 'description': 'Signal to noise value of the anterior talofibular ligament'}], 'primaryOutcomes': [{'measure': 'The American Orthopaedic Foot and Ankle Society (AOFAS) score', 'timeFrame': 'postoperative AOFAS score at 1 year', 'description': 'This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.'}, {'measure': 'The American Orthopaedic Foot and Ankle Society (AOFAS) score', 'timeFrame': 'postoperative AOFAS score at 2 years', 'description': 'This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.'}, {'measure': 'The American Orthopaedic Foot and Ankle Society (AOFAS) score', 'timeFrame': 'postoperative AOFAS score at 6 months', 'description': 'This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.'}, {'measure': 'The American Orthopaedic Foot and Ankle Society (AOFAS) score', 'timeFrame': 'postoperative AOFAS score at 3 months', 'description': 'This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Anterior displacement and talar tilt angle in stress radiography', 'timeFrame': 'postoperative radiographic measures at 2 years', 'description': 'The outcomes are common indicators for evaluation the lateral stability of ankle, and can be evaluated through same stress radiography'}, {'measure': 'Rate of re-injury', 'timeFrame': 'the rate of re-injury at 2 years', 'description': 'The rate of patients re-sprain after the surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankle Sprain', 'Hypermobility, Joint']}, 'referencesModule': {'references': [{'pmid': '34252562', 'type': 'BACKGROUND', 'citation': 'Wittig U, Hohenberger G, Ornig M, Schuh R, Reinbacher P, Leithner A, Holweg P. Improved Outcome and Earlier Return to Activity After Suture Tape Augmentation Versus Brostrom Repair for Chronic Lateral Ankle Instability? A Systematic Review. Arthroscopy. 2022 Feb;38(2):597-608. doi: 10.1016/j.arthro.2021.06.028. Epub 2021 Jul 9.'}, {'pmid': '27496909', 'type': 'BACKGROUND', 'citation': 'Xu HX, Lee KB. Modified Brostrom Procedure for Chronic Lateral Ankle Instability in Patients With Generalized Joint Laxity. Am J Sports Med. 2016 Dec;44(12):3152-3157. doi: 10.1177/0363546516657816. Epub 2016 Aug 5.'}]}, 'descriptionModule': {'briefSummary': 'GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. Additional suture tape augmentation has been suggested to provide more strength and stability. However, the outcomes of the MBP with suture tape augmentation were unknown, which requires further exploration.', 'detailedDescription': 'Generalized joint laxity (GJL) is a risk factor for postoperative recurrent instability following an open modified Broström repair (MBR) for chronic lateral ankle instability (CLAI). MBR with suture tape augmentation may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape. In addition, the outcomes of the MBP with suture tape augmentation were unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients who go to visit a doctor for persistent lateral ankle pain and instability over three months and invalid conservative treatment, with the age of 15 - 55 years. If the Beighton score of the patient is ≥4 and the exclusion criteria are met, he or she is going to be advised to participate in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of lateral ankle instability\n* Beighton score ≥4\n* Age with 18 to 60 years\n\nExclusion Criteria:\n\n* Patients with an acute or subacute ankle injury\n* Injury of the deltoid ligament\n* Alignment of lower extremity greater than 5 degrees\n* Fractures of the lower extremity\n* Stage III or IV osteoarthritis\n* Patients who refused to participate in the study'}, 'identificationModule': {'nctId': 'NCT06897293', 'briefTitle': 'Comparison of MBR + Suture Tape and MBR for CLAI in GJL Cases: A Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Comparison of Modified Broström Repair + Suture Tape and Modified Broström Repair for CLAI in Chronic Lateral Ankle Instability in Generalized Joint Laxity Cases: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'M2024292'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Open Modified Broström +Suture tape augmentation group', 'description': 'Patients who accept a modified Broström procedure + Suture tape augmentation operation', 'interventionNames': ['Procedure: Modified Broström procedure + Suture tape augmentation operation']}, {'label': 'Open Modified Broström group', 'description': 'Patients who accept a modified Broström procedure operation', 'interventionNames': ['Procedure: Modified Broström procedure operation']}], 'interventions': [{'name': 'Modified Broström procedure + Suture tape augmentation operation', 'type': 'PROCEDURE', 'description': 'Patients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation', 'armGroupLabels': ['Open Modified Broström +Suture tape augmentation group']}, {'name': 'Modified Broström procedure operation', 'type': 'PROCEDURE', 'description': 'Patients with CLAI and GJL will accept the Modified Broström procedure operation', 'armGroupLabels': ['Open Modified Broström group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dong Jiang, MD', 'role': 'CONTACT', 'email': 'bysyjiangdong@126.com', 'phone': '13811280948'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Dong Jiang, MD', 'role': 'CONTACT', 'email': 'bysyjiangdong@126.com', 'phone': '13811280948'}, {'name': 'Haoxuan Liu, MD', 'role': 'CONTACT', 'email': '2210301304@stu.pku.edu.cn', 'phone': '13716163357'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The demographics data, Beighton score, primary and secondary outcomes would be available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Jiang Dong', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}