Outcomes Following Surgical Versus Nonsurgical Treatment of Fibular Fractures Following Operative Fixation of Unstable Medial Malleolus Fractures: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- clinical outcomes
研究概览
简要总结
Isolated surgical repair of the inside portion of the tibia may be enough to stabilize an ankle fracture in which both the tibia and the fibula are broken. This would alleviate the need for another incision, plate, and screws to repair the fibula. The purpose of this study is to help determine if surgically repairing only the tibia fracture will lead to equivalent clinical outcomes when compared with surgical repair of both bones.
The hypothesis of this study is that operative stabilization of the medial malleolus fracture only, in otherwise ligamentously stable bimalleolar and/or trimalleolar fractures of the ankle, will lead to equivalent clinical outcomes and functional scores as those treated with operative stabilization of both malleoli and/or all malleoli.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature patients ≥ 18 years of age with acute, closed bimalleolar and/or trimalleolar ankle fractures
- •Operative fixation of the ankle fracture is within 3 weeks from date of injury
- •Bimalleolar and/or trimalleolar ankle fractures in which the medial malleolus fragment is greater than 1.7cm wide on lateral x-ray imaging
- •Bimalleolar and/or trimalleolar ankle fractures in which the posterior malleolus fragment is less than 20% of the depth of the tibial articular surface
排除标准
- •Skeletally immature patients < 18 years of age
- •Single malleolar ankle fractures
- •Open fractures
- •Operative fixation of the ankle fracture is more than 3 weeks from date of injury
- •Bimalleolar and/or trimalleolar fractures in which the medial malleolar fragment is less than or equal to 1.7cm wide on lateral x-ray imaging
- •Bimalleolar and/or trimalleolar ankle fractures in which the posterior malleolus fragment is greater than or equal to 20% of the depth of the tibial articular surface
- •Ankles with previous fractures of the medial and/or lateral malleolus requiring operative intervention
研究组 & 干预措施
Nonsurgical
Randomized to "nonsurgical": patient will receive surgical treatment of the inside portion (medial malleolus) of the tibia fracture only; the fibula fracture (and posterior malleolus fracture, if present) will be closed reduced (not repaired surgically).
干预措施: Nonsurgical (Procedure)
Surgical
Randomized to "surgical": patient will receive surgical treatment of both the inside portion (medial malleolus) of the tibia fracture, as well as the fibula fracture (lateral malleolus). Fixation of the posterior side of the tibia (posterior malleolus) may or may not be performed based upon intraoperative x-rays.
干预措施: Surgical (Procedure)
syndesmotic injury
Non-randomized / "syndesmotic injury": patients who have a positive ligament stress test (signifying a syndesmotic injury) during surgery will require surgical treatment of both the tibia and the fibula and cannot be randomized to either arm ("nonsurgical" versus "surgical"). Patients in this arm will still be included in the study for the collection of clinical and functional outcomes.
干预措施: Surgical (Procedure)
结局指标
主要结局
clinical outcomes
时间窗: one year
Time to union (radiographic healing of the fracture), Time to weight-bearing, Complications
次要结局
- functional outcomes(one year)