Single-window versus two-window posterolateral surgery for malleolar (ankle) fractures
Comparison of Single-Window and Two-Window Posterolateral Approaches in Posterior and Lateral Malleolus Fractures: A Clinical Outcomes Analysis
This trial will see if using a single-window posterolateral approach with a posterior antiglide plate instead of a two-window approach with a lateral anatomic plate leads to fewer wound problems while keeping the ankle stable in adults with posterior and lateral malleolus fractures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT07481266 on ClinicalTrials.gov |
What this trial studies
This prospective clinical trial enrolls adults with acute, closed ankle fractures that involve both the posterior and lateral malleoli and treats them via a posterolateral approach using one of two fixation strategies. One group receives a single-window approach with a posterior antiglide plate, and the other group receives a two-window approach with a lateral anatomic fibular plate. Patients are followed for 12 months with scheduled checks of wound healing, ankle range of motion, implant irritation, and functional recovery. The primary hypothesis is that the single-window technique reduces soft-tissue dissection and early wound complications without compromising biomechanical stability or functional outcomes.
Who should consider this trial
Good fit: Adults aged 18–65 with acute, closed unstable rotational ankle fractures involving the posterior and lateral malleoli who require fixation via a posterolateral approach and can comply with 12 months of follow-up are ideal candidates.
Not a fit: Patients with open fractures, extensive intra-articular comminution, severe tibial pilon variants, or those who demonstrate persistent syndesmotic instability requiring additional syndesmotic fixation are unlikely to benefit from the techniques tested in this protocol.
Why it matters
Potential benefit: If successful, the single-window approach could reduce early wound complications and later implant irritation while preserving fracture stability and functional recovery.
How similar studies have performed: Previous case series and smaller comparative reports have suggested antiglide posterior plating may reduce wound problems in some settings, but high-quality comparative data are limited and not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 (e.g., Bartonicek Type II, III, or IV). * Ability to provide informed consent and willingness to comply with the 12-month postoperative rehabilitation and follow-up protocol. Exclusion Criteria: * Open fractures, severe tibial pilon variants, or fractures with intra-articular comminution extending beyond the posterior malleolus. * Persistent Syndesmotic Instability: Patients demonstrating persistent distal tibiofibular syndesmotic instability (confirmed by intraoperative hook test) after the fixation of the posterior and lateral malleoli, which inherently requires additional trans-syndesmotic fixation (e.g., syndesmotic screws or suture-button devices). This exclusion is strictly applied to eliminate methodological bias, as the experimental single-window approach intentionally restricts direct lateral access for trans-syndesmotic interventions. * Delayed surgical intervention exceeding 7 days from the initial trauma, leading to organized hematoma or compromised soft-tissue envelopes. * 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.
Where this trial is running
Ankara
- Ankara Bilkent City Hospital — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Muhammed Kilic, MD — Ankara City Hospital Bilkent
- Study coordinator: Muhammed Kilic, MD
- Email: dr.kilic.06@gmail.com
- Phone: +905077707553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.