Grenoble Alpes university Hospital
La Tronche, 38700, France
Location contact
Mehdi BOUDISSA, Pr
PRINCIPAL_INVESTIGATOR
Sarah KASSAR-UNEISI, Pharm D
CONTACT
CONTACT
NCT Number: NCT07365202
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.
Trial opening soon.
Get Notified18 year–100 year
All sexes
Observational
La Tronche, 38700, France
Mehdi BOUDISSA, Pr
PRINCIPAL_INVESTIGATOR
Sarah KASSAR-UNEISI, Pharm D
CONTACT
CONTACT
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 year
Achieving consolidation without skin complications and without the need for hardware removal.
Time frame: 1 year
Achieving consolidation without skin complications and without the need for hardware removal.
Time frame: 1 year
Radiological criteria of McLenann et al (assessment of the quality of radiological reduction)
Time frame: 1 year
Clinical scores of Olerud and Molander (ankle function score)
Time frame: 1 year
Clinical scores of VAS (visual analog scale) , from 0 to 10 (0-10) 0 non pain 10 extreme pain
Time frame: 1 year
Clinical scores of EFAS (ankle function score)
Time frame: 1 year
Clinical scores of EQ5D-5L (quality of life)
Time frame: 1 year
Complications: re-operation(s), infection, healing disorders, secondary displacement, discomfort from osteosynthesis material, removal of osteosynthesis material
Contact information is provided by the study sponsor or research team.
Mehdi BOUDISSA, Pr
CONTACT
Sarah KASSAR-UNEISI, Pharm D
CONTACT
University Hospital, Grenoble
Other
Osteosynthesis of Fibula Fractures With a Locked Thin Plate: a Single-center Retrospective Series.
Acronym: OFFPAV
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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.