Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:25 AM
Study NCT ID:
NCT07365202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteosynthesis of Fibula Fractures With a Locked Thin Plate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-15', 'studyFirstSubmitDate': '2026-01-06', 'studyFirstSubmitQcDate': '2026-01-15', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the clinical of patients treated for fixation of an external malleolus fracture, whether isolated or associated with a bi malleolar, tri malleolar, or tibial pilon injury, using a low profile anatomical plate.', 'timeFrame': '1 year', 'description': 'Achieving consolidation without skin complications and without the need for hardware removal.\n\n* Consolidation is defined as the absence of visible fractures on standard anteroposterior and lateral ankle X-rays at 6 months post-operation.\n* The absence of skin complications is defined as wound healing achieved within the expected theoretical healing period (1 month).\n* The absence of a need for hardware removal is defined as the lack of necessity, one year after surgery, for the patient to have the hardware removed due to discomfort caused by the implant.'}, {'measure': 'Evaluate radiological outcomes of patients treated for fixation of an external malleolus fracture, whether isolated or associated with a bi malleolar, tri malleolar, or tibial pilon injury, using a low profile anatomical plate.', 'timeFrame': '1 year', 'description': 'Achieving consolidation without skin complications and without the need for hardware removal.\n\n* Consolidation is defined as the absence of visible fractures on standard anteroposterior and lateral ankle X-rays at 6 months post-operation.\n* The absence of skin complications is defined as wound healing achieved within the expected theoretical healing period (1 month).\n* The absence of a need for hardware removal is defined as the lack of necessity, one year after surgery, for the patient to have the hardware removed due to discomfort caused by the implant.'}], 'secondaryOutcomes': [{'measure': 'Assessment of the quality of radiological reduction', 'timeFrame': '1 year', 'description': 'Radiological criteria of McLenann et al (assessment of the quality of radiological reduction)'}, {'measure': 'Evaluation of clinical outcomes: Ankle functional scores', 'timeFrame': '1 year', 'description': 'Clinical scores of Olerud and Molander (ankle function score)'}, {'measure': 'Evaluation of clinical outcomes: Pain', 'timeFrame': '1 year', 'description': 'Clinical scores of VAS (visual analog scale) , from 0 to 10 (0-10) 0 non pain 10 extreme pain'}, {'measure': 'Evaluation of clinical outcomes: Ankle functional scores', 'timeFrame': '1 year', 'description': 'Clinical scores of EFAS (ankle function score)'}, {'measure': 'Evaluation of clinical outcomes: Quality of life', 'timeFrame': '1 year', 'description': 'Clinical scores of EQ5D-5L (quality of life)'}, {'measure': 'Evaluation of complications', 'timeFrame': '1 year', 'description': 'Complications: re-operation(s), infection, healing disorders, secondary displacement, discomfort from osteosynthesis material, removal of osteosynthesis material'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteosynthesis of Fibula Fractures With a Locked Thin Plate']}, 'descriptionModule': {'briefSummary': 'Ankle fractures represent about 10% of all fractures and are common in both elderly patients with comorbidities and younger polytraumatized individuals. Traditional fibular osteosynthesis uses open plating, which carries up to a 20% complication rate, mainly due to skin issues. These complications are more frequent in patients with diabetes, vascular or neurological disease, obesity, or tobacco/alcohol use, as well as in open fractures or fracture-dislocations. Standard plates can also cause long-term discomfort due to their thickness, often requiring removal.\n\nRecent meta-analyses show that fibular nailing and thin one-third tubular plates result in fewer complications than anatomical plates, while maintaining similar bone-healing rates (97-100%). New thinner locked plates (2.8 mm) have been developed to reduce skin risks and discomfort; biomechanical studies suggest superior strength. Clinical research is needed to confirm their effectiveness and tolerance.', 'detailedDescription': 'Ankle fractures account for up to 10% of all fractures. They are the third most common fracture site in adults, with nearly 169 cases per 100,000 inhabitants per year . These injuries affect a heterogeneous population, including elderly patients who often have comorbidities as well as younger polytraumatized individuals. Fibular osteosynthesis is traditionally performed by open reduction and internal fixation using plates with screws, either locked or non-locked. The longitudinal approach required for osteosynthesis carries risks, with complication rates reaching up to 20% in some series, the most common being skin complications related to the necessary incision .\n\nThe rate of cutaneous complications is associated with age, diabetes, peripheral vascular and neurological diseases, obesity, and alcohol or tobacco use . Moreover, an open injury or a fracture-dislocation further increases this risk. In addition, the plates traditionally used have a certain thickness that can cause long-term discomfort, often requiring hardware removal after bone healing. Recent meta-analyses published show a superiority of fibular nailing-and even simple one-third tubular plates-over so-called "anatomical" plates in terms of complications (patient discomfort, infection, and wound-healing issues), due to the smaller profile of the implants. Bone-healing rates remain comparable across different fixation methods and range from 97% to 100% in recent meta-analyses.\n\nRecently, new implants have been developed to reduce skin risks and discomfort related to implant thickness. These thinner locked plates have a thickness of 2.8 mm (compared with an average of 3.5 mm for competing systems). A recent biomechanical study demonstrated their superior mechanical resistance . A clinical study would be useful to confirm these results in terms of bone healing and tolerance (cutaneous tolerance and implant-related discomfort).\n\nStudy designe:Descriptive single-center historico-prospective observational cohort study without a control group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In this study, all adult patients treated for a lateral malleolus fracture with an anatomically contoured plate, either alone or associated with a bimalleolar, trimalleolar, or tibial pilon injury in the orthopedic and trauma department at Grenoble University Hospital, between 04/01/2025 (the date of first use of the contoured plate) and 1 year post-surgery, may be selected.\n\nEpidemiological data, preoperative management, fracture types according to the Weber and AO/OTA classifications \\[12\\], operative data, as well as radiological data are collected and analyzed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient at the time of injury\n\n • Patient who underwent surgery with a low-profile plate, including:\n * Isolated lateral malleolar fracture treated with a low-profile anatomical plate\n * Lateral malleolar fracture associated with a bimalleolar injury treated with a low-profile anatomical plate\n * Lateral malleolar fracture associated with a trimalleolar injury treated with a low-profile anatomical plate\n * Lateral malleolar fracture associated with a tibial pilon injury treated with a low-profile anatomical plate\n* Standard preoperative radiographs (ankle AP and lateral views)\n* Standard postoperative radiographs (ankle AP and lateral views)\n* No objection to participation in the study\n\nExclusion Criteria:\n\n* Individuals deprived of liberty by judicial or administrative decision, or individuals under legal protection\n* Patients with dementia preventing the collection of secondary clinical outcome measures (Olerud and Molander score, VAS, EFAS score, EQ-5D-5L)'}, 'identificationModule': {'nctId': 'NCT07365202', 'acronym': 'OFFPAV', 'briefTitle': 'Osteosynthesis of Fibula Fractures With a Locked Thin Plate', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Osteosynthesis of Fibula Fractures With a Locked Thin Plate: a Single-center Retrospective Series.', 'orgStudyIdInfo': {'id': '38RC25.0227'}}, 'contactsLocationsModule': {'locations': [{'zip': '38700', 'city': 'La Tronche', 'country': 'France', 'contacts': [{'name': 'Sarah KASSAR-UNEISI, Pharm D', 'role': 'CONTACT', 'email': 'suneisi@chu-grenoble.fr', 'phone': '0033476767524'}, {'role': 'CONTACT', 'email': 'mboudissa@chu-grenoble.fr'}, {'name': 'Mehdi BOUDISSA, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Grenoble Alpes university Hospital', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}], 'centralContacts': [{'name': 'Mehdi BOUDISSA, Pr', 'role': 'CONTACT', 'email': 'mboudissa@chu-grenoble.fr', 'phone': '0033476763275'}, {'name': 'Sarah KASSAR-UNEISI, Pharm D', 'role': 'CONTACT', 'email': 'suneisi@chu-grenoble.fr', 'phone': '0033476767524'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}