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Ankle Fractures:Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula NailsOFCCFNCT06518265

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

An observational study of Ankle Fractures:Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails, run by University Hospital, Grenoble at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
How many people
15 participants
Where
1 siteFrance
Study dates
1 Jul 2024to Jul 2025
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This single-center observational study selects all patients treated in the orthopedics and traumatology department at Grenoble Alpes University Hospital between 01/01/2021 and 12/31/2023 for an unstable ankle fracture with high cutaneous risk. Epidemiological data, preoperative management, operative data and radiological criteria are collected and analyzed retrospectively.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mehdi PI BOUDISSA, Pr contact

0033476769693

MBoudissa@chu-grenoble.fr

Sarah KASSAR-UNEISI, Pharm-D contact

0033476767524

SUneisi@chu-grenoble.fr

France1 site, 1 recruiting
  • Grenoble Alpes university Hospital,La tronche

    La Tronche, 38700

    Sarah PI KASSAR-UNEISI, Pharm D, 0033476767524, suneisi@chu-grenoble.fr

    Mehdi BOUDISSA, Pr

    Recruiting

Other trials in France

About this study

Official title: Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails: What Results for Which Patients? A Monocentric Case Series

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.

Read more

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.

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the clinical and radiological results of patients treated for fixation of an unstable ankle fracture with high cutaneous risk including a fibula nail without access to the fibular fracture site.

    obtaining bone consolidation (healing) without cutaneous complications.

    Measured: 1 year

Secondary outcomes (9)
  1. Evaluation of the quality of the radiological reduction.

    Radiological criteria of McLenann

    Measured: 1 year

  2. Evaluation of clinical results

    Clinical scores of EFAS

    Measured: 1 year

  3. Evaluation of clinical results

    Clinical scores of Olerud and Molander

    Measured: 1 year

  4. Evaluation of clinical results

    Clinical scores of Kitaoka hindfoot

    Measured: 1 year

  5. Assessment of complications

    Complications: re-intervention(s)

    Measured: 1 year

  6. Assessment of complications

    Complications: infection

    Measured: 1 year

  7. Assessment of complications

    Complications: healing disorders

    Measured: 1 year

  8. Assessment of complications

    Complications: secondary displacement

    Measured: 1 year

  9. Assessment of complications

    Complications: discomfort of osteosynthesis equipment

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2024
  2. Study start1 Jul 2024
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
15 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06518265
Sponsor's protocol ID
2024-A00925-42
Acronym
OFCCF
Status last verified
Jul 2024
First submitted
11 Jul 2024
Last updated
24 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ankle Fractures:Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mehdi PI BOUDISSA, Pr (0033476769693, MBoudissa@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the clinical and radiological results of patients treated for fixation of an unstable ankle fracture with high cutaneous risk including a fibula nail without access to the fibular fracture site. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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