Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT06518265

Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails: What Results for Which Patients?

Led by University Hospital, Grenoble · Updated on 2024-07-24

15

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Ankle fractures are among the most common injuries in orthopedic and trauma surgery, accounting for 9% of all fractures. They can be classified into isolated malleolar fractures (internal and/or external), pilon fractures, and distal tibia fractures, which affect the entire distal part of the tibia, depending on whether they are intra-articular or extra-articular. The aging of the population and the increase in survival of multiple trauma patients lead to an increase in ankle fractures with high skin risk, whether due to an open fracture, soft tissue injury (crush, dermabrasion, etc.). ) or a major risk of scarring (chronic venous insufficiency, lymphedema, unbalanced diabetes. The fibula nail is a recent, minimally invasive osteosynthesis method whose results seem at least equivalent to those of screwed plate osteosynthesis in numerous series in the literature. The most commonly used and most studied fibula nail in the literature is the Acumed fibula nail. In recent literature, the use of the fibula nail in the fixation of tibial pilon fractures and/or fractures of the distal quarter of the leg is associated with satisfactory results. The elements collected as part of this study could make it possible to validate the use of the fibula nail in the management strategy for these fractures and thus better codify and standardize practices in this restricted and complex area of traumatology.

CONDITIONS

Official Title

Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails: What Results for Which Patients?

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient at the time of injury
  • Unstable fracture of one or both ankles: tri-malleolar fracture, distal quarter of the leg, tibial pilon
  • High skin risk including acute traumatic tissue injury with or without open fracture evaluated by Oestern and Tscherne classification, or chronic skin diseases such as lipodermatosclerosis, lymphedema, varicose or arterial ulcers, and skin atrophy from long-term corticosteroid therapy
  • Standard preoperative ankle X-rays (face and profile)
  • Standard postoperative ankle X-rays (face and profile)
  • No opposition to participation in the study
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Individuals under guardianship, curatorship, deprived of liberty, or under legal protection
  • Individuals who are cognitively unable to answer the questionnaire

AI-Screening

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Trial Site Locations

Total: 1 location

1

Grenoble Alpes university Hospital,La tronche

La Tronche, France, 38700

Actively Recruiting

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Research Team

M

Mehdi PI BOUDISSA, Pr

CONTACT

S

Sarah KASSAR-UNEISI, Pharm-D

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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