Sinus Tarsi Versus Extensile Lateral Approach for Open Reduction Internal Fixation of Intra-articular Calcaneus Fractures
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Wound complication rate
研究概览
简要总结
This study is a prospective, randomized controlled trial comparing the sinus tarsi approach to the extensile lateral approach for surgical fixation of calcaneus fractures.
It is hypothesized that open reduction and internal fixation of intra-articular calcaneus fractures using a sinus tarsi approach will provide equivalent fracture reduction and stable fixation with significantly decreased wound complication rates in comparison to an extensile lateral approach.
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
- •Closed intra-articular calcaneus fractures
- •Undergoing surgical fixation (CPT code 28415)
- •Ability to understand and agree to informed consent
排除标准
- •Patients < 18 years of age
- •Open fractures
- •Dislocations that require open reduction
- •Previous calcaneus abnormality or injury
- •Unable to understand or agree to informed consent
研究组 & 干预措施
Sinus Tarsi approach
The Sinus Tarsi approach is the surgical approach for the incision.
干预措施: Sinus Tarsi approach (Procedure)
Extensile Lateral approach
The Extensile Lateral approach is the surgical approach for the incision.
干预措施: Extensile Lateral approach (Procedure)
结局指标
主要结局
Wound complication rate
时间窗: approximately one year
There is an expected wound complication rate of up to 30% with this type of fracture. The difference in wound complication rate between the two surgical approaches will be the primary outcome measure. Wound complications will be defined by the presence of superficial or deep infections, skin edge necrosis, and soft tissue sloughing.
次要结局
- Fracture healing(approximately one year)
- Rate of secondary surgery(approximately one year)
- Change in operative time(one day)
- Rate of sural nerve injury(approximately one year)
- American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale(approximately one year)
- Rate of peroneal tendon injury(approximately one year)
- Visual Analog Scale(approximately one year)
- Foot Function Index(approximately one year)
- Short-Form 36 (SF-36) Health Survey(approximately one year)