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.
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
- Conditions the study is for
- Ankle Fractures:Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails
- 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.
France1 site, 1 recruiting
- Recruiting
Grenoble Alpes university Hospital,La tronche
La Tronche, 38700
Sarah PI KASSAR-UNEISI, Pharm D, 0033476767524, suneisi@chu-grenoble.fr
Mehdi BOUDISSA, Pr
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.
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)
Evaluation of the quality of the radiological reduction.
Radiological criteria of McLenann
Measured: 1 year
Evaluation of clinical results
Clinical scores of EFAS
Measured: 1 year
Evaluation of clinical results
Clinical scores of Olerud and Molander
Measured: 1 year
Evaluation of clinical results
Clinical scores of Kitaoka hindfoot
Measured: 1 year
Assessment of complications
Complications: re-intervention(s)
Measured: 1 year
Assessment of complications
Complications: infection
Measured: 1 year
Assessment of complications
Complications: healing disorders
Measured: 1 year
Assessment of complications
Complications: secondary displacement
Measured: 1 year
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.
- First posted24 Jul 2024
- Study start1 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Fractures:Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula NailsStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails: What Results for Which Patients? A Monocentric Case Series
- ClinicalTrials.gov ID
- NCT06518265
- Acronym / sponsor ID
- OFCCF / 2024-A00925-42
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
obtaining bone consolidation (healing) without cutaneous complications.
9 secondary outcomes
Evaluation of the quality of the radiological reduction.
Time frame: 1 year
Evaluation of clinical results
Time frame: 1 year
Evaluation of clinical results
Time frame: 1 year
Evaluation of clinical results
Time frame: 1 year
Assessment of complications
Time frame: 1 year
Assessment of complications
Time frame: 1 year
Assessment of complications
Time frame: 1 year
Assessment of complications
Time frame: 1 year
Assessment of complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.