Osteosynthesis of Fibula Fractures With a Locked Thin PlateOFFPAVNCT07365202
Osteosynthesis of Fibula Fractures With a Locked Thin Plate
An observational study of Osteosynthesis of Fibula Fractures With a Locked Thin Plate, run by University Hospital, Grenoble at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteosynthesis of Fibula Fractures With a Locked Thin Plate
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2026to 15 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: In this study, all adult patients treated for a lateral malleolus fracture with an anatomically contoured plate, either alone or associated with a bimalleolar, trimalleolar, or tibial pilon injury in the orthopedic and trauma department at Grenoble University Hospital, between 04/01/2025 (the date of first use of the contoured plate) and 1 year post-surgery, may be selected. Epidemiological data, preoperative management, fracture types according to the Weber and AO/OTA classifications [12], operative data, as well as radiological data are collected and analyzed.
Who may be able to join
- Adult patient at the time of injury
- Patient who underwent surgery with a low-profile plate, including:
- Isolated lateral malleolar fracture treated with a low-profile anatomical plate
- Lateral malleolar fracture associated with a bimalleolar injury treated with a low-profile anatomical plate
- Lateral malleolar fracture associated with a trimalleolar injury treated with a low-profile anatomical plate
- Lateral malleolar fracture associated with a tibial pilon injury treated with a low-profile anatomical plate
Show all 9Show fewer
- Standard preoperative radiographs (ankle AP and lateral views)
- Standard postoperative radiographs (ankle AP and lateral views)
- No objection to participation in the study
Who cannot join
- Individuals deprived of liberty by judicial or administrative decision, or individuals under legal protection
- Patients with dementia preventing the collection of secondary clinical outcome measures (Olerud and Molander score, VAS, EFAS score, EQ-5D-5L)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Grenoble Alpes university Hospital
La Tronche, 38700
Sarah KASSAR-UNEISI, Pharm D, 0033476767524, suneisi@chu-grenoble.fr
mboudissa@chu-grenoble.fr
About this study
Official title: Osteosynthesis of Fibula Fractures With a Locked Thin Plate: a Single-center Retrospective Series.
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.
Read the detailed description
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical of patients treated for fixation of an external malleolus fracture, whether isolated or associated with a bi malleolar, tri malleolar, or tibial pilon injury, using a low profile anatomical plate.
Achieving consolidation without skin complications and without the need for hardware removal.
- Consolidation is defined as the absence of visible fractures on standard anteroposterior and lateral ankle X-rays at 6 months post-operation.
- The absence of skin complications is defined as wound healing achieved within the expected theoretical healing period (1 month).
- The absence of a need for hardware removal is defined as the lack of necessity, one year after surgery, for the patient to have the hardware removed due to discomfort caused by the implant.
Measured: 1 year
Evaluate radiological outcomes of patients treated for fixation of an external malleolus fracture, whether isolated or associated with a bi malleolar, tri malleolar, or tibial pilon injury, using a low profile anatomical plate.
Achieving consolidation without skin complications and without the need for hardware removal.
- Consolidation is defined as the absence of visible fractures on standard anteroposterior and lateral ankle X-rays at 6 months post-operation.
- The absence of skin complications is defined as wound healing achieved within the expected theoretical healing period (1 month).
- The absence of a need for hardware removal is defined as the lack of necessity, one year after surgery, for the patient to have the hardware removed due to discomfort caused by the implant.
Measured: 1 year
Secondary outcomes (6)
Assessment of the quality of radiological reduction
Radiological criteria of McLenann et al (assessment of the quality of radiological reduction)
Measured: 1 year
Evaluation of clinical outcomes: Ankle functional scores
Clinical scores of Olerud and Molander (ankle function score)
Measured: 1 year
Evaluation of clinical outcomes: Pain
Clinical scores of VAS (visual analog scale) , from 0 to 10 (0-10) 0 non pain 10 extreme pain
Measured: 1 year
Evaluation of clinical outcomes: Ankle functional scores
Clinical scores of EFAS (ankle function score)
Measured: 1 year
Evaluation of clinical outcomes: Quality of life
Clinical scores of EQ5D-5L (quality of life)
Measured: 1 year
Evaluation of complications
Complications: re-operation(s), infection, healing disorders, secondary displacement, discomfort from osteosynthesis material, removal of osteosynthesis material
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 posted26 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteosynthesis of Fibula Fractures With a Locked Thin PlateStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365202
- Sponsor's protocol ID
- 38RC25.0227
- Acronym
- OFFPAV
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 26 Jan 2026
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteosynthesis of Fibula Fractures With a Locked Thin Plate: a Single-center Retrospective Series.
- ClinicalTrials.gov ID
- NCT07365202
- Acronym / sponsor ID
- OFFPAV / 38RC25.0227
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 26 Jan 2026 (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 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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, all adult patients treated for a lateral malleolus fracture with an anatomically contoured plate, either alone or associated with a bimalleolar, trimalleolar, or tibial pilon injury in the orthopedic and trauma department at Grenoble University Hospital, between 04/01/2025 (the date of first use of the contoured plate) and 1 year post-surgery, may be selected. Epidemiological data, preoperative management, fracture types according to the Weber and AO/OTA classifications [12], operative data, as well as radiological data are collected and analyzed.
Key inclusion criteria (9 listed)
- Adult patient at the time of injury
- Standard preoperative radiographs (ankle AP and lateral views)
- Standard postoperative radiographs (ankle AP and lateral views)
- No objection to participation in the study
Key exclusion criteria (2 listed)
- Individuals deprived of liberty by judicial or administrative decision, or individuals under legal protection
- Patients with dementia preventing the collection of secondary clinical outcome measures (Olerud and Molander score, VAS, EFAS score, EQ-5D-5L)
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 of patients treated for fixation of an external malleolus fracture, whether isolated or associated with a bi malleolar, tri malleolar, or tibial pilon injury, using a low profile anatomical plate.
Time frame: 1 year
Achieving consolidation without skin complications and without the need for hardware removal. * Consolidation is defined as the absence of visible fractures on standard anteroposterior and lateral ankle X-rays at 6 months post-operation. * The absence of skin complications is defined as wound healing achieved within the expected theoretical healing period (1 month). * The absence of a need for hardware removal is defined as the lack of necessity, one year after surgery, for the patient to have the hardware removed due to discomfort caused by the implant.
Evaluate radiological outcomes of patients treated for fixation of an external malleolus fracture, whether isolated or associated with a bi malleolar, tri malleolar, or tibial pilon injury, using a low profile anatomical plate.
Time frame: 1 year
Achieving consolidation without skin complications and without the need for hardware removal. * Consolidation is defined as the absence of visible fractures on standard anteroposterior and lateral ankle X-rays at 6 months post-operation. * The absence of skin complications is defined as wound healing achieved within the expected theoretical healing period (1 month). * The absence of a need for hardware removal is defined as the lack of necessity, one year after surgery, for the patient to have the hardware removed due to discomfort caused by the implant.
6 secondary outcomes
Assessment of the quality of radiological reduction
Time frame: 1 year
Evaluation of clinical outcomes: Ankle functional scores
Time frame: 1 year
Evaluation of clinical outcomes: Pain
Time frame: 1 year
Evaluation of clinical outcomes: Ankle functional scores
Time frame: 1 year
Evaluation of clinical outcomes: Quality of life
Time frame: 1 year
Evaluation of complications
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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.
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 Osteosynthesis of Fibula Fractures With a Locked Thin Plate, 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 9 inclusion and 2 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: opening soon, as of the sponsor's last update on 26 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehdi BOUDISSA, Pr (0033476763275, 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 of patients treated for fixation of an external malleolus fracture, whether isolated or associated with a bi malleolar, tri malleolar, or tibial pilon injury, using a low profile anatomical plate. (time frame: 1 year). The study lists 2 primary outcomes in all. 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 26 Jan 2026.