Ankle FracturesNCT07481266
Single-Window Versus Two-Window Posterolateral Approach for Malleolar Fractures
A study testing Single-Window Posterolateral Approach and Two-Window Posterolateral Approach in people with Ankle Fractures and Posterior Malleolus Fractures, run by muhammed kılıç at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this prospective clinical trial is to compare the clinical outcomes and early complication rates of two different surgical techniques used during the posterolateral approach for ankle fractures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Fractures, Posterior Malleolus Fractures, Lateral Malleolus Fracture
- What is being tested?
- Single-Window Posterolateral Approach and Two-Window Posterolateral Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2024to Oct 2027
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65 years.
- Diagnosis of an acute, closed, unstable rotational ankle fracture with concomitant involvement of the posterior malleolus and lateral malleolus (trimalleolar or bimalleolar equivalent fractures).
- Fracture morphology explicitly indicating surgical reduction and internal fixation via a posterolateral approach
- Ability to provide informed consent and willingness to comply with the 12-month postoperative rehabilitation and follow-up protocol.
Who cannot join
- Open fractures, severe tibial pilon variants, or fractures with intra-articular comminution extending beyond the posterior malleolus.
- Delayed surgical intervention exceeding 7 days from the initial trauma, leading to organized hematoma or compromised soft-tissue envelopes.
- Syndesmotic instability requiring additional trans-syndesmotic fixation (screws or suture buttons), identified before randomization.
- Pre-existing conditions detrimental to soft-tissue healing and functional assessment, including severe peripheral arterial disease, uncontrolled diabetes mellitus with neuropathy, or severe ipsilateral ankle osteoarthritis.
- Previous history of ipsilateral ankle fractures or surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Window Versus Two-Window Posterolateral Approach for Malleolar Fractures: A Prospective Randomized Comparison of Clinical and Radiological Outcomes
The purpose of this prospective clinical trial is to compare the clinical outcomes and early complication rates of two different surgical techniques used during the posterolateral approach for ankle fractures. Participants with fractures involving the posterior and lateral malleoli will undergo surgery using either a single-window technique or a two-window technique. The main question the study aims to answer is whether the single-window approach reduces complications rates by minimizing surgical dissection, without compromising fracture stability. Patients will be followed for 12 months to assess wound healing, ankle range of motion, tendon irritation, and functional recovery.
Read the detailed description
Ankle fractures involving the posterior malleolus are complex injuries that require anatomical reduction and stable fixation to prevent post-traumatic osteoarthritis. The posterolateral surgical approach allows direct visualization and fixation of both the posterior and lateral malleoli through a single incision. However, the optimal deep dissection technique and fibular plating strategy remain controversial.
The traditional two-window technique involves creating one interval medial to the peroneal tendons for posterior malleolus fixation, and a second interval lateral to the peroneal tendons to apply a standard lateral anatomic plate to the fibula. Alternatively, the single-window technique utilizes only the interval medial to the peroneal tendons to fix both malleoli, utilizing a posterior antiglide plate for the fibula.
This prospective study aims to compare the clinical and functional outcomes of these two techniques. The primary hypothesis is that the single-window approach will significantly minimize soft-tissue stripping, thereby reducing the incidence of early complications while providing excellent biomechanical stability against external rotation forces.
Patients with acute, closed ankle fractures involving both the distal fibula and the posterior malleolus will be included. Clinical evaluations will include the assessment of early complications (dehiscence, delayed healing, necrosis, infection, tendon irritation) within the first 3 months, as well as functional outcomes using the American Orthopaedic Foot and Ankle Society (AOFAS) score, range of motion, and Visual Analog Scale (VAS) for pain at 6 and 12 months postoperatively.
- Being tested
- Single-Window Posterolateral Approach, Two-Window Posterolateral Approach
- Keywords
- Posterolateral approach, Single-window technique, Posterior antiglide plate, Two-window technique, Wound complication, Trimalleolar fracture, Ankle Fractures
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Window Posterolateral ApproachProcedure or surgery
Also called Single-interval posterolateral approach
Posterolateral approach with a single deep soft-tissue window between the peroneal tendons and the flexor hallucis longus, through which both the posterior malleolus and the lateral malleolar (fibular) fracture are reduced and fixed. Fibular plate type is selected intraoperatively according to fracture morphology.
Two-Window Posterolateral ApproachProcedure or surgery
Also called Two-interval posterolateral approach
Posterolateral approach in which the posterior malleolus is fixed through the posterolateral window, and a second, more lateral window is developed by retracting the peroneal tendons to expose the fibula directly for fixation of the lateral malleolar fracture. Fibular plate type is selected intraoperatively according to fracture morphology.
| Study group | Role | What they receive |
|---|---|---|
| Single-Window Approach | Experimental | Patients in this arm will undergo surgical fixation of the ankle fracture using a single-window posterolateral approach. Both the posterior malleolus and the lateral malleolus (fibula) will be accessed and reduced through a single surgical interval medial to the peroneal tendons (between the peroneal tendons and the flexor hallucis longus muscle). No additional lateral surgical window will be created. Receives: Procedure: Single-Window Posterolateral Approach |
| Two-Window Approach | Active comparator | Patients in this arm will undergo surgical fixation of the unstable ankle fracture using a two-window posterolateral approach. The posterior malleolus will be accessed and fixed through the first interval medial to the peroneal tendons. A second surgical interval (lateral window) will be intentionally developed lateral to the peroneal tendons to access and fix the fibula. Receives: Procedure: Two-Window Posterolateral Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Complications
The total number of participants experiencing any early postoperative complications at the surgical site. This includes tendon irritation, wound dehiscence, superficial or deep surgical site infection, wound edge necrosis, and delayed wound healing.
Measured: Up to 3 months postoperatively
Secondary outcomes (3)
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
Functional outcome will be evaluated using the AOFAS ankle-hindfoot scale. The total score ranges from 0 to 100, with higher scores indicating better functional recovery.
Measured: 6 and 12 months postoperatively
Ankle Range of Motion (ROM)
Objective measurement of the ankle joint's maximal plantarflexion and dorsiflexion angles in degrees, assessed using a standard clinical goniometer.
Measured: 12 months postoperatively
Visual Analog Scale (VAS) for Pain
Asessment of patient-reported pain intensity during weight-bearing. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: 6 and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start14 Feb 2024
- Primary completionFeb 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- muhammed kılıç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, muhammed kılıç, Ankara City Hospital Bilkent
- Investigators
- Muhammed Kilic, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481266
- Sponsor's protocol ID
- TABED 1/14/2024
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional patient privacy regulations.
Publications
Herbosa CG, Leucht P, Egol KA, Tejwani NC. The 2-Window Posterolateral vs Single-Window Approach for Ankle Fracture Fixation. Foot Ankle Int. 2023 Apr;44(4):297-307. doi: 10.1177/10711007231156163. Epub 2023 Mar 22.
PubMed 36946551Deng Y, Staniforth TL, Zafar MS, Lau YJ. Posterior Antiglide Plating vs Lateral Neutralization Plating for Weber B Distal Fibular Fractures: A Systematic Review and Meta-analysis of Clinical and Biomechanical Studies. Foot Ankle Int. 2022 Jun;43(6):850-859. doi: 10.1177/10711007221079617. Epub 2022 Apr 2.
PubMed 35373597Gu Y, Zhao L, Ren Y, Wang Y, Xu C, Jiang C. Modified Posterolateral Approach for the Treatment of 2-Part Fractures of the Posterior Malleolus Associated with Medial and Lateral Malleolar Fractures: 1 Incision, 2 Windows, 3 Steel Plates. Med Sci Monit. 2022 May 28;28:e936039. doi: 10.12659/MSM.936039.
PubMed 35633024
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Window Versus Two-Window Posterolateral Approach for Malleolar Fractures: A Prospective Randomized Comparison of Clinical and Radiological Outcomes
- ClinicalTrials.gov ID
- NCT07481266
- Acronym / sponsor ID
- TABED 1/14/2024
- Keywords
- Posterolateral approach, Single-window technique, Posterior antiglide plate, Two-window technique, Wound complication, Trimalleolar fracture, Ankle Fractures
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- muhammed kılıçUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 18 Mar 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.
The purpose of this prospective clinical trial is to compare the clinical outcomes and early complication rates of two different surgical techniques used during the posterolateral approach for ankle fractures. Participants with fractures involving the posterior and lateral malleoli will undergo surgery using either a single-window technique or a two-window technique. The main question the study aims to answer is whether the single-window approach reduces complications rates by minimizing surgical dissection, without compromising fracture stability. Patients will be followed for 12 months to assess wound healing, ankle range of motion, tendon irritation, and functional recovery.
Detailed description
Ankle fractures involving the posterior malleolus are complex injuries that require anatomical reduction and stable fixation to prevent post-traumatic osteoarthritis. The posterolateral surgical approach allows direct visualization and fixation of both the posterior and lateral malleoli through a single incision. However, the optimal deep dissection technique and fibular plating strategy remain controversial.
The traditional two-window technique involves creating one interval medial to the peroneal tendons for posterior malleolus fixation, and a second interval lateral to the peroneal tendons to apply a standard lateral anatomic plate to the fibula. Alternatively, the single-window technique utilizes only the interval medial to the peroneal tendons to fix both malleoli, utilizing a posterior antiglide plate for the fibula.
This prospective study aims to compare the clinical and functional outcomes of these two techniques. The primary hypothesis is that the single-window approach will significantly minimize soft-tissue stripping, thereby reducing the incidence of early complications while providing excellent biomechanical stability against external rotation forces.
Patients with acute, closed ankle fractures involving both the distal fibula and the posterior malleolus will be included. Clinical evaluations will include the assessment of early complications (dehiscence, delayed healing, necrosis, infection, tendon irritation) within the first 3 months, as well as functional outcomes using the American Orthopaedic Foot and Ankle Society (AOFAS) score, range of motion, and Visual Analog Scale (VAS) for pain at 6 and 12 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Window Approach | Experimental | Procedure: Single-Window Posterolateral ApproachPatients in this arm will undergo surgical fixation of the ankle fracture using a single-window posterolateral approach. Both the posterior malleolus and the lateral malleolus (fibula) will be accessed and reduced through a single surgical interval medial to the peroneal tendons (between the peroneal tendons and the flexor hallucis longus muscle). No additional lateral surgical window will be created. |
| Two-Window Approach | Active comparator | Procedure: Two-Window Posterolateral ApproachPatients in this arm will undergo surgical fixation of the unstable ankle fracture using a two-window posterolateral approach. The posterior malleolus will be accessed and fixed through the first interval medial to the peroneal tendons. A second surgical interval (lateral window) will be intentionally developed lateral to the peroneal tendons to access and fix the fibula. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 18 and 65 years.
- Diagnosis of an acute, closed, unstable rotational ankle fracture with concomitant involvement of the posterior malleolus and lateral malleolus (trimalleolar or bimalleolar equivalent fractures).
- Fracture morphology explicitly indicating surgical reduction and internal fixation via a posterolateral approach
- Ability to provide informed consent and willingness to comply with the 12-month postoperative rehabilitation and follow-up protocol.
Key exclusion criteria (5 listed)
- Open fractures, severe tibial pilon variants, or fractures with intra-articular comminution extending beyond the posterior malleolus.
- Delayed surgical intervention exceeding 7 days from the initial trauma, leading to organized hematoma or compromised soft-tissue envelopes.
- Syndesmotic instability requiring additional trans-syndesmotic fixation (screws or suture buttons), identified before randomization.
- Pre-existing conditions detrimental to soft-tissue healing and functional assessment, including severe peripheral arterial disease, uncontrolled diabetes mellitus with neuropathy, or severe ipsilateral ankle osteoarthritis.
- Previous history of ipsilateral ankle fractures or surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Window Posterolateral ApproachAlso: Single-interval posterolateral approachPosterolateral approach with a single deep soft-tissue window between the peroneal tendons and the flexor hallucis longus, through which both the posterior malleolus and the lateral malleolar (fibular) fracture are reduced and fixed. Fibular plate type is selected intraoperatively according to fracture morphology. | Procedure or surgery | Single-Window Approach |
| Two-Window Posterolateral ApproachAlso: Two-interval posterolateral approachPosterolateral approach in which the posterior malleolus is fixed through the posterolateral window, and a second, more lateral window is developed by retracting the peroneal tendons to expose the fibula directly for fixation of the lateral malleolar fracture. Fibular plate type is selected intraoperatively according to fracture morphology. | Procedure or surgery | Two-Window Approach |
Primary outcome
Incidence of Complications
Time frame: Up to 3 months postoperatively
The total number of participants experiencing any early postoperative complications at the surgical site. This includes tendon irritation, wound dehiscence, superficial or deep surgical site infection, wound edge necrosis, and delayed wound healing.
3 secondary outcomes
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
Time frame: 6 and 12 months postoperatively
Ankle Range of Motion (ROM)
Time frame: 12 months postoperatively
Visual Analog Scale (VAS) for Pain
Time frame: 6 and 12 months postoperatively
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 8 Oct 2026.
- Background: PubMed 36946551Herbosa CG, Leucht P, Egol KA, Tejwani NC. The 2-Window Posterolateral vs Single-Window Approach for Ankle Fracture Fixation. Foot Ankle Int. 2023 Apr;44(4):297-307. doi: 10.1177/10711007231156163. Epub 2023 Mar 22.
- Background: PubMed 35373597Deng Y, Staniforth TL, Zafar MS, Lau YJ. Posterior Antiglide Plating vs Lateral Neutralization Plating for Weber B Distal Fibular Fractures: A Systematic Review and Meta-analysis of Clinical and Biomechanical Studies. Foot Ankle Int. 2022 Jun;43(6):850-859. doi: 10.1177/10711007221079617. Epub 2022 Apr 2.
- Background: PubMed 35633024Gu Y, Zhao L, Ren Y, Wang Y, Xu C, Jiang C. Modified Posterolateral Approach for the Treatment of 2-Part Fractures of the Posterior Malleolus Associated with Medial and Lateral Malleolar Fractures: 1 Incision, 2 Windows, 3 Steel Plates. Med Sci Monit. 2022 May 28;28:e936039. doi: 10.12659/MSM.936039.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional patient privacy regulations.
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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.
Muhammed Kilic, MD principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Window Posterolateral Approach and Two-Window Posterolateral Approach in people with Ankle Fractures and Posterior Malleolus Fractures, run by muhammed kılıç at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Complications (time frame: Up to 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07481266, which also lists 3 linked publications.
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 8 Oct 2026.