Comparison Between Fibula Plating Versus Intramedullary K-Wire With Medial Malleolar Screw for the Fixation of Bimalleolar Fracture of Ankle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Comparison of Functional Outcome Using Olerud-Molander Ankle (OMA) Score at 3 Months Between Fibula Plating and Intramedullary K-Wire Fixation
研究概览
简要总结
This study was conducted to compare the functional outcomes of two commonly used fixation techniques for bimalleolar ankle fractures: fibula plating and intramedullary K-wire fixation with medial malleolar screw. Bimalleolar fractures are commonly caused by rotational injuries, often due to low-energy trauma such as falls, although high-energy mechanisms like road traffic accidents can result in more complex fracture patterns with associated soft tissue injury. The ankle joint is a complex osteoligamentous structure, and its stability depends on both proper bony alignment and intact ligamentous support, necessitating careful clinical and radiological assessment.
The deltoid ligament plays a key role in maintaining medial ankle stability, and its injury can lead to instability and poor functional outcomes. Initial evaluation should include neurovascular assessment and examination of soft tissues, as these factors influence management decisions. Most bimalleolar fractures are unstable and are treated surgically with open reduction and internal fixation. Fibula plating provides strong biomechanical stability but requires more extensive soft tissue dissection, increasing the risk of wound-related complications. In contrast, intramedullary K-wire fixation is a minimally invasive technique that may reduce soft tissue damage, though its functional effectiveness compared to plating remains unclear.
This randomized controlled trial was conducted at the Orthopaedic Department of PGMI / Shaikh Zayed Hospital, Lahore, over six months following ethical approval. A total of 200 patients aged 18-60 years with radiographically confirmed bimalleolar ankle fractures were included. After informed consent, patients were randomly assigned into two groups using the lottery method. Group A underwent fibula plating, while Group B received intramedullary K-wire fixation with medial malleolar screw.
Standardized surgical procedures were followed in both groups, with fixation of the lateral malleolus followed by the medial malleolus. Postoperatively, patients were immobilized and received routine care. Functional outcomes were assessed at three months using the Olerud-Molander Ankle score. The objective was to compare mean OMA scores between groups to determine the more effective technique for early functional recovery.
详细描述
This study was conducted to evaluate and compare the functional outcomes of two commonly employed surgical techniques for the management of bimalleolar ankle fractures: fibula plating and intramedullary K-wire fixation combined with medial malleolar screw fixation. Bimalleolar fractures of the ankle represent a significant portion of ankle injuries and are typically the result of rotational forces acting on the ankle joint. While low-energy mechanisms such as simple falls are common causes, there has been an increasing trend in high-energy trauma, particularly road traffic accidents, which has led to more complex fracture patterns with associated soft tissue injury.
The ankle joint is a highly complex structure composed of osseous and ligamentous components that function together to maintain stability and enable movement. Stability of the ankle depends not only on the integrity of the tibia, fibula, and talus but also on the surrounding ligamentous structures, particularly the deltoid ligament medially and the lateral ligament complex. Any disruption to this osteoligamentous unit can result in joint instability, altered biomechanics, and long-term functional impairment if not managed appropriately.
The deltoid ligament, in particular, plays a critical role in maintaining medial stability of the ankle joint. Injury to this ligament, whether partial or complete, can lead to significant instability, widening of the medial clear space, and potential long-term complications such as chronic pain, deformity, and post-traumatic arthritis. Therefore, a thorough clinical and radiological evaluation is essential in all cases of ankle fractures. Initial assessment should include neurovascular examination to rule out any compromise in circulation, as well as careful evaluation of soft tissue condition, as open fractures or severe soft tissue injury may significantly influence treatment options and prognosis.
Management of bimalleolar ankle fractures is generally surgical, as these injuries are considered unstable. Open reduction and internal fixation (ORIF) has long been considered the gold standard for treatment, particularly for achieving anatomical alignment, restoring joint congruity, and allowing early mobilization. Traditional fibular plating techniques provide rigid fixation and excellent stability; however, they require extensive soft tissue dissection, which may increase the risk of complications such as wound infection, skin necrosis, and delayed healing. These concerns have led to the exploration of less invasive fixation methods.
Intramedullary K-wire fixation represents a minimally invasive alternative that aims to reduce soft tissue disruption while still providing adequate stabilization of the fibula. This technique may be associated with reduced operative time, smaller incisions, and potentially fewer wound-related complications. However, concerns remain regarding the adequacy of fixation strength, maintenance of reduction, and overall functional outcomes when compared to traditional plating methods. Despite increasing use of this technique, there is limited high-quality comparative data evaluating its effectiveness, particularly in relation to early functional recovery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years age, both genders
- •Patients having bimalleolar fracture of ankle
排除标准
- •Compound fractures
- •Associated with other fractures
- •Cases which were treated by non-operative methods
研究组 & 干预措施
Fibula Plating Intervention Arm
Participants in this arm underwent open reduction and internal fixation of the fibula using a one-third tubular plate. A standard lateral approach was used to expose the fracture site, and careful soft tissue handling was performed to avoid neurovascular injury. The fracture was anatomically reduced and stabilized with a plate and screws under tourniquet control. Medial malleolar fractures were then fixed using a malleolar screw through an anteromedial approach. Postoperatively, patients were immobilized in a below-knee slab, received antibiotics, and were followed for functional outcome assessment using the OMA score at three months.
干预措施: Fibula Plating Intervention Arm (Device)
Intramedullary K-Wire Fixation Arm
Participants in this arm underwent intramedullary fixation of the fibula using a Kirschner wire inserted under fluoroscopic guidance through a small incision to minimize soft tissue disruption. Anatomical reduction was achieved and maintained with the K-wire within the fibular canal. The medial malleolus was then fixed using a malleolar screw through an anteromedial approach after temporary K-wire stabilization. The procedure was performed under tourniquet control. Postoperatively, patients were immobilized in a below-knee slab, received antibiotics, and were followed up, with functional outcomes assessed at three months using the OMA score.
干预措施: Fibula Plating Intervention Arm (Device)
结局指标
主要结局
Comparison of Functional Outcome Using Olerud-Molander Ankle (OMA) Score at 3 Months Between Fibula Plating and Intramedullary K-Wire Fixation
时间窗: 3 months postoperatively after surgical intervention
The primary outcome measure was the functional outcome of patients assessed using the Olerud-Molander Ankle (OMA) score. This score evaluated ankle function based on pain, stiffness, swelling, stair climbing ability, use of supports, ability to perform daily activities, and participation in sports. The total score ranged from 0 to 100, with higher scores indicating better functional recovery. The OMA score was used to compare outcomes between the fibula plating group and the intramedullary K-wire with medial malleolar screw group.
次要结局
- Comparison of Functional Outcome Stratified by Age, Gender, BMI, and Ankle Side Between Treatment Groups(3 months postoperatively after surgical intervention)
研究者
Mian Abdullah Anwar
Dr.
Shaikh Zayed Hospital, Lahore
