Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-09 @ 7:34 PM
Study NCT ID:
NCT02998333
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2016-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Ankle Instability, Surgical Repair: Open Versus Closed
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': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2016-12-16', 'studyFirstSubmitQcDate': '2016-12-19', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional outcome', 'timeFrame': '6 months', 'description': 'The primary outcome measures is a difference in pain and disability between both treatment groups as measured a Functional Ankle Outcome Score (FAOS) score change of ≥2 points per subscale measured at 6 months follow-up.'}], 'secondaryOutcomes': [{'measure': 'Functional outcome FAOS', 'timeFrame': '3- and 6 months', 'description': 'For assessment disablement'}, {'measure': 'Functional outcome Numeric Rating Scale (NRS) pain', 'timeFrame': '3- and 6 months', 'description': 'For pain assessment'}, {'measure': 'Functional outcome Cumberland Ankle Instability Tool (CAIT)', 'timeFrame': '3- and 6 months', 'description': 'For instability assessment'}, {'measure': 'Anterior Drawer Test (ADT)', 'timeFrame': 'Pre-operative, instraoperative, 3- and 6 months postoperative', 'description': 'The anterior drawer test is registered per mm (range 0-15mm) displacement and according to the manual anterior drawer test (M-ATT) categories (grade 0-3).'}, {'measure': 'Range of Motion (ROM)', 'timeFrame': 'Pre-operative, instraoperative, 3- and 6 months postoperative', 'description': 'ROM is registered in degrees of dorsi- and plantarflexion and is measured using a goniometer. Assessment is performed pre-operatively, and at 3- and 6-months postoperatively.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Instability', 'Ankle', 'Surgical stabilization'], 'conditions': ['Chronic Ankle Instability']}, 'referencesModule': {'references': [{'pmid': '24962695', 'type': 'BACKGROUND', 'citation': 'Kobayashi T, Gamada K. Lateral Ankle Sprain and Chronic Ankle Instability: A Critical Review. Foot Ankle Spec. 2014 Aug 1;7(4):298-326. doi: 10.1177/1938640014539813. Epub 2014 Jun 24.'}, {'pmid': '5339635', 'type': 'BACKGROUND', 'citation': 'Brostrom L. Sprained ankles. VI. Surgical treatment of "chronic" ligament ruptures. Acta Chir Scand. 1966 Nov;132(5):551-65. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Mabit, C.C., J.M.; Fiorenza, F.; Huc, H.; Pecout, C., Lateral ligament reconstruction of the ankle: comparative study of peroneus brevis tenodesis versus periosteal ligamentoplasty. Foot and Ankle Surgery, 1998. 4(2): p. 6.'}, {'pmid': '27073785', 'type': 'BACKGROUND', 'citation': 'Pereira H, Vuurberg G, Gomes N, Oliveira JM, Ripoll PL, Reis RL, Espregueira-Mendes J, Niek van Dijk C. Arthroscopic Repair of Ankle Instability With All-Soft Knotless Anchors. Arthrosc Tech. 2016 Feb 1;5(1):e99-e107. doi: 10.1016/j.eats.2015.10.010. eCollection 2016 Feb.'}, {'pmid': '24850160', 'type': 'BACKGROUND', 'citation': 'Drakos MC, Behrens SB, Paller D, Murphy C, DiGiovanni CW. Biomechanical Comparison of an Open vs Arthroscopic Approach for Lateral Ankle Instability. Foot Ankle Int. 2014 Aug;35(8):809-815. doi: 10.1177/1071100714535765. Epub 2014 May 21.'}, {'pmid': '26467354', 'type': 'BACKGROUND', 'citation': 'Matsui K, Takao M, Miyamoto W, Matsushita T. Early recovery after arthroscopic repair compared to open repair of the anterior talofibular ligament for lateral instability of the ankle. Arch Orthop Trauma Surg. 2016 Jan;136(1):93-100. doi: 10.1007/s00402-015-2342-3. Epub 2015 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'Rationale: Lateral ankle ligament injuries may be a result of ankle sprains. In 10-30% of patients with lateral ankle ligament injuries, chronic lateral ankle instability may be present. If conservative treatment fails, instability is treated surgically. Anatomic repair (also known as the Bröstrom procedure) is the current golden standard for surgical treatment of chronic ankle instability. The Bröstrom started out as an open technique and is now also performed arthroscopically. Both approaches are considered standard care and provide good results. Which approach is best, has not yet been researched. In this study it is hypothesized arthroscopic repair provides better functional outcome compared to open repair during short term follow-up.\n\nObjective: The main objective of this study is to compare the functional outcome after arthroscopic and open anatomic repair in patients with chronic lateral ankle instability, and secondly to assess ankle stability and ankle Range of Motion (ROM) after arthroscopic and open ligament repair.\n\nStudy design: A Non-Blinded Prospective Randomized Controlled Trial Study population: All patients willing to participate, from an age of 18 years old, with persisting ankle instability for at least 6 months, eligible for anatomic repair.\n\nIntervention: Both groups of patients are surgically treated with anatomic repair of the anterior talofibular ligament (ATFL). One group is treated arthroscopically and the other by the open approach.\n\nMain study parameters/endpoints: The primary outcome measure is functional outcome 6 months after surgery measured using the Foot and Ankle Outcome Score. The main study parameter is a difference of ≥10 2 points per FAOS subscale between both treatment groups (Minimal Important Change = 10 points; 2 per subscale).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are 18 years or older;\n* Experience pain and/or a sensation of instability during sports and/or daily activity;\n* Isolated lateral ankle instability;\n* Planned for surgical repair of the ATFL;\n* At least one previous episode of an ankle inversion sprain;\n* Complaints for at least 6 months;\n* Failed previous conservative treatment.\n\nExclusion Criteria:\n\n* Serious concomitant injury (like arthrosis, ruled out using an AP and lateral x-ray according to standard protocol);\n* Foot or ankle fracture in past;\n* Previous foot or ankle surgery;\n* ROM restriction of \\>10 degrees;\n* Medial instability;\n* Severe misalignment;\n* Ankle/foot deformities (e.g. severe flat foot);\n* Systemic comorbidity leading to delayed recovery (e.g. Diabetes Mellitus, Rheumatoid Arthritis)\n* (general) Hyper laxity\n* Inability or unwillingness to provide consent\n* Present factors that may cause difficulty of follow-up'}, 'identificationModule': {'nctId': 'NCT02998333', 'acronym': 'CAISR', 'briefTitle': 'Chronic Ankle Instability, Surgical Repair: Open Versus Closed', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Does Arthroscopic Anatomic Repair of the Anterior Talofibular Ligament Provide Better Functional Outcome Compared to Open Anatomic Repair in Patients With Chronic Ankle Instability: a Multicentre Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2016_136#B2016709'}, 'secondaryIdInfos': [{'id': 'NL55707.018.16', 'type': 'REGISTRY', 'domain': 'ABR-form (toetsingonline.nl)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Open surgical ankle stabilization', 'description': 'These patients will receive open surgical stabilization of the ankle joint after failed conservative treatment with complaints for at least 6 months.', 'interventionNames': ['Procedure: Surgical stabilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arthroscopic surgical ankle stabilization', 'description': 'These patients will receive arthroscopic surgical stabilization of the ankle joint after failed conservative treatment with complaints for at least 6 months.', 'interventionNames': ['Procedure: Surgical stabilization']}], 'interventions': [{'name': 'Surgical stabilization', 'type': 'PROCEDURE', 'description': 'Surgical stabilization of the ankle joint, performed as an open or arthroscopic procedure.', 'armGroupLabels': ['Arthroscopic surgical ankle stabilization', 'Open surgical ankle stabilization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Porto', 'country': 'Portugal', 'facility': 'Centro Hospitalar Povoa deVarzim', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Site Hôpital orthopédique', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'G.M.M.J. Kerkhoffs, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopaedic Surgery, AMC, Amsterdam, The Netherlands'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gwendolyn Vuurberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, {'name': 'Centro Hospitalar do Porto', 'class': 'OTHER'}, {'name': 'Site Hôpital orthopédique', 'class': 'UNKNOWN'}, {'name': 'Amphia Hospital', 'class': 'OTHER'}, {'name': 'Albert Schweitzer Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Gwendolyn Vuurberg', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}