Osteosynthesis of Fibula Fractures With a Locked Thin Plate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Osteosynthesis of Fibula Fractures With a Locked Thin Plate. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Osteosynthesis of Fibula Fractures With a Locked Thin Plate: a Single-center Retrospective Series.
Overview
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. Recent 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.
Detailed description
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 .
The 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.
Recently, 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).
Study designe:Descriptive single-center historico-prospective observational cohort study without a control group
Primary outcome measures
- 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. [Time frame: 1 year]
- 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. [Time frame: 1 year]
Secondary outcome measures (6)
- Assessment of the quality of radiological reduction [Time frame: 1 year]
- Evaluation of clinical outcomes: Ankle functional scores [Time frame: 1 year]
- Evaluation of clinical outcomes: Pain [Time frame: 1 year]
- Evaluation of clinical outcomes: Ankle functional scores [Time frame: 1 year]
- Evaluation of clinical outcomes: Quality of life [Time frame: 1 year]
- Evaluation of complications [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Adult patient at the time of injury
- Patient who underwent surgery with a low-profile plate, including:
- Isolated lateral malleolar fracture treated with a low-profile anatomical plate
- Lateral malleolar fracture associated with a bimalleolar injury treated with a low-profile anatomical plate
- Lateral malleolar fracture associated with a trimalleolar injury treated with a low-profile anatomical plate
- Lateral malleolar fracture associated with a tibial pilon injury treated with a low-profile anatomical plate
- Standard preoperative radiographs (ankle AP and lateral views)
- Standard postoperative radiographs (ankle AP and lateral views)
- No objection to participation in the study
Exclusion criteria
- Individuals deprived of liberty by judicial or administrative decision, or individuals under legal protection
- Patients with dementia preventing the collection of secondary clinical outcome measures (Olerud and Molander score, VAS, EFAS score, EQ-5D-5L)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Grenoble Alpes university Hospital — La Tronche
Identifiers
NCT: NCT07365202 · 38RC25.0227