Comparison of Single-Window and Two-Window Posterolateral Approaches in Posterior and Lateral Malleolus Fractures: A Clinical Outcomes Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Wound Complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor evaluating the postoperative functional scores, range of motion, and wound complications will be blinded to the surgical approach group of the patients.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Single-Window Approach (Posterior Antiglide Plate)
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). The fibula will be fixed using a posterior antiglide plate. No additional lateral surgical window will be created.
干预措施: Posterior Antiglide Plating (Procedure)
Two-Window Approach (Lateral Anatomic Plate)
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 using a standard lateral anatomic plate.
干预措施: Lateral Anatomic Plating (Procedure)
结局指标
主要结局
Incidence of Wound Complications
时间窗: 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.
次要结局
- Ankle Range of Motion (ROM)(12 months postoperatively)
- American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score(6 and 12 months postoperatively)
- Visual Analog Scale (VAS) for Pain(6 and 12 months postoperatively)
研究者
muhammed kılıç
Resident in Orthopedics and Traumatology
Ankara City Hospital Bilkent