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

NCT ID: NCT06518265

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-07-31

Brief Summary

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.

Detailed Description

Ankle fractures represent one of the most common injuries in orthopedic and trauma surgery with an incidence of 9% of all fractures. We distinguish between isolated fractures of the malleolus (internal and/or external), fractures of the tibial pilon and the distal quarter of the leg which concern the entire distal part of the tibia depending on whether they are intra- 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, etc.).

The classic management of fractures of the fibula (external malleolus) is based on open reduction-fixation using a screwed plate, made through a longitudinal incision. Restoring the length of the fibula contributes to the reduction of fractures of the tibial pilon. However, in patients at high skin risk, plate fixation increases tissue trauma and can lead to scar complications and infections.

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 [BÄCKER 2019]. 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.

If the fibula nail seems equivalent to the screwed plate in "classic" ankle fractures, we can wonder if its minimally invasive nature does not give it an advantage over the screwed plate in the fixation of ankle fractures. high skin risk. To our knowledge, few series have been published concerning this subpopulation at risk and for which the fibula nail represents an interesting alternative.

Likewise, although a biomechanical study showed a higher rate of torsional fracture after fibula nail fixation versus screwed plate, the results of fibula nail fixation in unstable ankle fractures appear equivalent to those of fixing by screwed plates. As the notion of stability of ankle fractures is not clearly defined in the literature, we will refer to tri-malleolar fractures, dislocated bi-malleolar fractures, tibial pilon fractures and fractures of the distal quarter of the leg as unstable fractures. As the notion of skin risk is not clearly defined in the literature, we will designate as skin risk patients presenting with acute traumatic tissue damage associated or not with an open fracture evaluated according to the Oestern and Tscherne classification as well as patients presenting with a skin disease. chronic such as lipodermatosclerosis, lymphedema, varicose or arterial ulcer and skin atrophy secondary to long-term corticosteroid therapy compromising the healing of a longitudinal incision next to the fibula.

Expected benefits:

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

Ankle Fractures:Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 (acute traumatic tissue injury associated or not with an open fracture evaluated according to the Oestern and Tscherne classification, chronic skin disease such as lipodermatosclerosis, lymphedema, varicose or arterial ulcer and skin atrophy secondary to corticosteroid therapy long course compromising the healing of a longitudinal incision next to the fibula).
• Standard preoperative x-ray image (ankle face and profile)
• Standard image post-operative x-rays (ankle face and profile)
• No opposition to participation in the study.

Exclusion Criteria

• Pregnant, breastfeeding women.
• Subject under guardianship, curatorship, deprived of liberty or under the protection of justice.
• Subject who are cognitively incapable of answering the questionnaire.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Grenoble Alpes university Hospital,La tronche

La Tronche, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Mehdi PI BOUDISSA, Pr

Role: CONTACT

MBoudissa@chu-grenoble.fr

0033476769693

Sarah KASSAR-UNEISI, Pharm-D

Role: CONTACT

SUneisi@chu-grenoble.fr

0033476767524

Facility Contacts

Sarah PI KASSAR-UNEISI, Pharm D

Role: primary

suneisi@chu-grenoble.fr

0033476767524

Other Identifiers

2024-A00925-42

Identifier Type: -

Identifier Source: org_study_id