Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:53 AM
Study NCT ID:
NCT07481266
Status:
RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-Window Versus Two-Window Posterolateral Approach for Malleolar Fractures
Sponsor:
muhammed kılıç
Organization:
Study Overview
Official Title:
Comparison of Single-Window and Two-Window Posterolateral Approaches in Posterior and Lateral Malleolus Fractures: A Clinical Outcomes Analysis
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this prospective clinical trial is to compare the clinical outcomes and early wound 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 (using a posterior antiglide plate) or a two-window technique (using a lateral anatomic plate). The main question the study aims to answer is whether the single-window approach reduces soft-tissue complications by minimizing surgical dissection, without compromising fracture stability. Patients will be followed for 12 months to assess wound healing, ankle range of motion, implant 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 with posterior antiglide plating will significantly minimize soft-tissue stripping, thereby reducing the incidence of early wound complications and late implant-related irritation, 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. To avoid confounding variables and methodological bias, patients demonstrating persistent syndesmotic instability that requires additional trans-syndesmotic fixation (screws or buttons) will be excluded from the study, as the single-window approach inherently restricts direct lateral access for such procedures. Clinical evaluations will include the assessment of early wound complications (dehiscence, necrosis, infection) 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.
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 with posterior antiglide plating will significantly minimize soft-tissue stripping, thereby reducing the incidence of early wound complications and late implant-related irritation, 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. To avoid confounding variables and methodological bias, patients demonstrating persistent syndesmotic instability that requires additional trans-syndesmotic fixation (screws or buttons) will be excluded from the study, as the single-window approach inherently restricts direct lateral access for such procedures. Clinical evaluations will include the assessment of early wound complications (dehiscence, necrosis, infection) 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: