Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
Location status: Recruiting
Location contact
Fatih İnci, Assoc Prof
CONTACT
Fatih İnci, Assoc Prof
SUB_INVESTIGATOR
Muhammed Kilic, MD
CONTACT
Muhammed Kilic, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07481266
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Ankara, 06800, Turkey (Türkiye)
Location status: Recruiting
Fatih İnci, Assoc Prof
CONTACT
Fatih İnci, Assoc Prof
SUB_INVESTIGATOR
Muhammed Kilic, MD
CONTACT
Muhammed Kilic, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fixation of the fibular fracture utilizing a posterior antiglide plate configuration applied directly to the posterior surface of the fibula.
Fixation of the fibular fracture utilizing a standard lateral anatomic plate configuration applied to the lateral surface of the fibula.
Time frame: Up to 3 months postoperatively
The total number of participants experiencing any early postoperative wound complications at the surgical site. This includes wound dehiscence, superficial or deep surgical site infection, wound edge necrosis, and delayed wound healing.
Time frame: 6 and 12 months postoperatively
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.
Time frame: 12 months postoperatively
Objective measurement of the ankle joint's maximal plantarflexion and dorsiflexion angles in degrees, assessed using a standard clinical goniometer.
Time frame: 6 and 12 months postoperatively
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.
Contact information is provided by the study sponsor or research team.
Fatih İnci, Assoc Prof
CONTACT
Muhammed Kilic, MD
CONTACT
muhammed kılıç
Other
Comparison of Single-Window and Two-Window Posterolateral Approaches in Posterior and Lateral Malleolus Fractures: A Clinical Outcomes Analysis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05413707
Ankle Fractures, Ankle Injuries
Bergen, Vestland, Norway
View Trial DetailsNCT05084794
Ankle Fractures, Ankle Injuries
View Trial DetailsNCT07620015
Ankle Fractures, Ankle Injuries
Kyrenia, Cyprus
View Trial DetailsNCT05280639
Ankle Fractures, Ankle Injuries
Charlottesville, Virginia, United States
View Trial Details