Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:53 AM
Study NCT ID:
NCT07481266
Status:
RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-Window Versus Two-Window Posterolateral Approach for Malleolar Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064386', 'term': 'Ankle Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessor evaluating the postoperative functional scores, range of motion, and wound complications will be blinded to the surgical approach group of the patients.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-15', 'studyFirstSubmitQcDate': '2026-03-15', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Wound Complications', 'timeFrame': 'Up to 3 months postoperatively', 'description': 'The total number of participants experiencing any early postoperative wound complications at the surgical site. This includes wound dehiscence, superficial or deep surgical site infection, wound edge necrosis, and delayed wound healing.'}], 'secondaryOutcomes': [{'measure': 'American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score', 'timeFrame': '6 and 12 months postoperatively', 'description': 'Functional outcome will be evaluated using the AOFAS ankle-hindfoot scale. The total score ranges from 0 to 100, with higher scores indicating better functional recovery.'}, {'measure': 'Ankle Range of Motion (ROM)', 'timeFrame': '12 months postoperatively', 'description': "Objective measurement of the ankle joint's maximal plantarflexion and dorsiflexion angles in degrees, assessed using a standard clinical goniometer."}, {'measure': 'Visual Analog Scale (VAS) for Pain', 'timeFrame': '6 and 12 months postoperatively', 'description': 'Asessment of patient-reported pain intensity during weight-bearing. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Posterolateral approach', 'Single-window technique', 'Posterior antiglide plate', 'Two-window technique', 'Wound complication', 'Trimalleolar fracture', 'Ankle Fractures'], 'conditions': ['Ankle Fractures', 'Posterior Malleolus Fractures', 'Lateral Malleolus Fracture']}, 'referencesModule': {'references': [{'pmid': '36946551', 'type': 'BACKGROUND', 'citation': 'Herbosa CG, Leucht P, Egol KA, Tejwani NC. The 2-Window Posterolateral vs Single-Window Approach for Ankle Fracture Fixation. Foot Ankle Int. 2023 Apr;44(4):297-307. doi: 10.1177/10711007231156163. Epub 2023 Mar 22.'}, {'pmid': '35373597', 'type': 'BACKGROUND', 'citation': 'Deng Y, Staniforth TL, Zafar MS, Lau YJ. Posterior Antiglide Plating vs Lateral Neutralization Plating for Weber B Distal Fibular Fractures: A Systematic Review and Meta-analysis of Clinical and Biomechanical Studies. Foot Ankle Int. 2022 Jun;43(6):850-859. doi: 10.1177/10711007221079617. Epub 2022 Apr 2.'}, {'pmid': '35633024', 'type': 'BACKGROUND', 'citation': 'Gu Y, Zhao L, Ren Y, Wang Y, Xu C, Jiang C. Modified Posterolateral Approach for the Treatment of 2-Part Fractures of the Posterior Malleolus Associated with Medial and Lateral Malleolar Fractures: 1 Incision, 2 Windows, 3 Steel Plates. Med Sci Monit. 2022 May 28;28:e936039. doi: 10.12659/MSM.936039.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective clinical trial is to compare the clinical outcomes and early wound complication rates of two different surgical techniques used during the posterolateral approach for ankle fractures. Participants with fractures involving the posterior and lateral malleoli will undergo surgery using either a single-window technique (using a posterior antiglide plate) or a two-window technique (using a lateral anatomic plate). The main question the study aims to answer is whether the single-window approach reduces soft-tissue complications by minimizing surgical dissection, without compromising fracture stability. Patients will be followed for 12 months to assess wound healing, ankle range of motion, implant irritation, and functional recovery.', 'detailedDescription': 'Ankle fractures involving the posterior malleolus are complex injuries that require anatomical reduction and stable fixation to prevent post-traumatic osteoarthritis. The posterolateral surgical approach allows direct visualization and fixation of both the posterior and lateral malleoli through a single incision. However, the optimal deep dissection technique and fibular plating strategy remain controversial.\n\nThe traditional two-window technique involves creating one interval medial to the peroneal tendons for posterior malleolus fixation, and a second interval lateral to the peroneal tendons to apply a standard lateral anatomic plate to the fibula. Alternatively, the single-window technique utilizes only the interval medial to the peroneal tendons to fix both malleoli, utilizing a posterior antiglide plate for the fibula.\n\nThis prospective study aims to compare the clinical and functional outcomes of these two techniques. The primary hypothesis is that the single-window approach with posterior antiglide plating will significantly minimize soft-tissue stripping, thereby reducing the incidence of early wound complications and late implant-related irritation, while providing excellent biomechanical stability against external rotation forces.\n\nPatients with acute, closed ankle fractures involving both the distal fibula and the posterior malleolus will be included. To avoid confounding variables and methodological bias, patients demonstrating persistent syndesmotic instability that requires additional trans-syndesmotic fixation (screws or buttons) will be excluded from the study, as the single-window approach inherently restricts direct lateral access for such procedures. Clinical evaluations will include the assessment of early wound complications (dehiscence, necrosis, infection) within the first 3 months, as well as functional outcomes using the American Orthopaedic Foot and Ankle Society (AOFAS) score, range of motion, and Visual Analog Scale (VAS) for pain at 6 and 12 months postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 65 years.\n* Diagnosis of an acute, closed, unstable rotational ankle fracture with concomitant involvement of the posterior malleolus and lateral malleolus (trimalleolar or bimalleolar equivalent fractures).\n* Fracture morphology explicitly indicating surgical reduction and internal fixation via a posterolateral approach (e.g., Bartonicek Type II, III, or IV).\n* Ability to provide informed consent and willingness to comply with the 12-month postoperative rehabilitation and follow-up protocol.\n\nExclusion Criteria:\n\n* Open fractures, severe tibial pilon variants, or fractures with intra-articular comminution extending beyond the posterior malleolus.\n* Persistent Syndesmotic Instability: Patients demonstrating persistent distal tibiofibular syndesmotic instability (confirmed by intraoperative hook test) after the fixation of the posterior and lateral malleoli, which inherently requires additional trans-syndesmotic fixation (e.g., syndesmotic screws or suture-button devices). This exclusion is strictly applied to eliminate methodological bias, as the experimental single-window approach intentionally restricts direct lateral access for trans-syndesmotic interventions.\n* Delayed surgical intervention exceeding 7 days from the initial trauma, leading to organized hematoma or compromised soft-tissue envelopes.\n* Pre-existing conditions detrimental to soft-tissue healing and functional assessment, including severe peripheral arterial disease, uncontrolled diabetes mellitus with neuropathy, or severe ipsilateral ankle osteoarthritis.\n* Previous history of ipsilateral ankle fractures or surgeries.'}, 'identificationModule': {'nctId': 'NCT07481266', 'briefTitle': 'Single-Window Versus Two-Window Posterolateral Approach for Malleolar Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparison of Single-Window and Two-Window Posterolateral Approaches in Posterior and Lateral Malleolus Fractures: A Clinical Outcomes Analysis', 'orgStudyIdInfo': {'id': 'TABED 1-24-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-Window Approach (Posterior Antiglide Plate)', 'description': 'Patients in this arm will undergo surgical fixation of the ankle fracture using a single-window posterolateral approach. Both the posterior malleolus and the lateral malleolus (fibula) will be accessed and reduced through a single surgical interval medial to the peroneal tendons (between the peroneal tendons and the flexor hallucis longus muscle). The fibula will be fixed using a posterior antiglide plate. No additional lateral surgical window will be created.', 'interventionNames': ['Procedure: Posterior Antiglide Plating']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Two-Window Approach (Lateral Anatomic Plate)', 'description': 'Patients in this arm will undergo surgical fixation of the unstable ankle fracture using a two-window posterolateral approach. The posterior malleolus will be accessed and fixed through the first interval medial to the peroneal tendons. A second surgical interval (lateral window) will be intentionally developed lateral to the peroneal tendons to access and fix the fibula using a standard lateral anatomic plate.', 'interventionNames': ['Procedure: Lateral Anatomic Plating']}], 'interventions': [{'name': 'Posterior Antiglide Plating', 'type': 'PROCEDURE', 'description': 'Fixation of the fibular fracture utilizing a posterior antiglide plate configuration applied directly to the posterior surface of the fibula.', 'armGroupLabels': ['Single-Window Approach (Posterior Antiglide Plate)']}, {'name': 'Lateral Anatomic Plating', 'type': 'PROCEDURE', 'description': 'Fixation of the fibular fracture utilizing a standard lateral anatomic plate configuration applied to the lateral surface of the fibula.', 'armGroupLabels': ['Two-Window Approach (Lateral Anatomic Plate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Muhammed Kilic, MD', 'role': 'CONTACT', 'email': 'dr.kilic.06@gmail.com', 'phone': '+905077707553'}, {'name': 'Fatih İnci, Assoc Prof', 'role': 'CONTACT', 'email': 'fatihinci@gmail.com', 'phone': '+905052325821'}, {'name': 'Muhammed Kilic, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fatih İnci, Assoc Prof', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Muhammed Kilic, MD', 'role': 'CONTACT', 'email': 'dr.kilic.06@gmail.com', 'phone': '+905077707553'}, {'name': 'Fatih İnci, Assoc Prof', 'role': 'CONTACT', 'email': 'fatihinci@gmail.com', 'phone': '+905052325821'}], 'overallOfficials': [{'name': 'Muhammed Kilic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to institutional patient privacy regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'muhammed kılıç', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident in Orthopedics and Traumatology', 'investigatorFullName': 'muhammed kılıç', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}