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NCT Number: NCT07365202

Osteosynthesis of Fibula Fractures With a Locked Thin Plate

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

    Achieving consolidation without skin complications and without the need for hardware removal.

    • Consolidation is defined as the absence of visible fractures on standard anteroposterior and lateral ankle X-rays at 6 months post-operation.
    • The absence of skin complications is defined as wound healing achieved within the expected theoretical healing period (1 month).
    • 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.
  2. 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

    Achieving consolidation without skin complications and without the need for hardware removal.

    • Consolidation is defined as the absence of visible fractures on standard anteroposterior and lateral ankle X-rays at 6 months post-operation.
    • The absence of skin complications is defined as wound healing achieved within the expected theoretical healing period (1 month).
    • 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.

Secondary outcomes

  1. Assessment of the quality of radiological reduction

    Time frame: 1 year

    Radiological criteria of McLenann et al (assessment of the quality of radiological reduction)

  2. Evaluation of clinical outcomes: Ankle functional scores

    Time frame: 1 year

    Clinical scores of Olerud and Molander (ankle function score)

  3. Evaluation of clinical outcomes: Pain

    Time frame: 1 year

    Clinical scores of VAS (visual analog scale) , from 0 to 10 (0-10) 0 non pain 10 extreme pain

  4. Evaluation of clinical outcomes: Ankle functional scores

    Time frame: 1 year

    Clinical scores of EFAS (ankle function score)

  5. Evaluation of clinical outcomes: Quality of life

    Time frame: 1 year

    Clinical scores of EQ5D-5L (quality of life)

  6. Evaluation of complications

    Time frame: 1 year

    Complications: re-operation(s), infection, healing disorders, secondary displacement, discomfort from osteosynthesis material, removal of osteosynthesis material

Study contacts

Contact information is provided by the study sponsor or research team.

Mehdi BOUDISSA, Pr

CONTACT

[email protected]

0033476763275

Sarah KASSAR-UNEISI, Pharm D

CONTACT

[email protected]

0033476767524

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Osteosynthesis of Fibula Fractures With a Locked Thin Plate: a Single-center Retrospective Series.

Acronym: OFFPAV

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.