Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach - A Randomized Controlled Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- Manchester-Oxford Foot Questionnaire (MOxFQ)
研究概览
简要总结
In this randomized controlled trial, the outcomes of two surgical techniques for intraarticular calcaneal fractures will be evaluated and compared.
详细描述
Operative treatment of calcaneal features through an extensile lateral approach (ELA) has been the gold standard over many years despite high rates of infection and soft tissue complications.
Lately, there has been a trend towards less invasive fixation methods. Minimally invasive plate osteosynthesis using the sinus tarsi approach (STA) has gained popularity during the last decade.
Furthermore, percutaneous reduction and fixation techniques have been described and used for a few decades. In the early 2000s, Rammelt et al. were the first who introduced a percutaneous technique assisted by hindfoot arthroscopy. The percutaneous and arthroscopically assisted calcaneal osteosynthesis (PACO) is applicable in Sanders II and III fractures and has been shown to provide good clinical outcomes as well as a low rate of complications.
The study is designed as a superiority study. Our hypothesis is that the percutaneous and arthroscopically assisted technique provides superior outcomes compared to the sinus tarsi approach in Sanders II and III calcaneal fractures.
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 (Investigator)
盲法说明
The investigators that will conduct the follow-up examinations 2 and 5 years after surgery will be blinded for the operative treatment.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dislocated intraarticular calcaneal fracture, type Sanders II or Sanders III with an intraarticular step > 2mm
- •Patients between 18 and 70 years of age
- •Acute presentation at one of our departments, enabling surgery within 10 days after injury
排除标准
- •Intraarticular step of < 2mm
- •Sanders IV fractures
- •Open fractures
- •Bilateral injuries
- •Concomitant major injuries of the foot, ankle or leg that affect the rehabilitation process
- •Multitraumized patients
- •Previous injury or surgery of the hindfoot
- •Charcot foot
- •Serious medical condition that contradicts surgery
- •Noncompliant patients
- •Insufficient Norwegian or English language skills
- •Patients not available for follow-up
- •Inability to conduct the rehabilitation protocol
结局指标
主要结局
Manchester-Oxford Foot Questionnaire (MOxFQ)
时间窗: 5 years
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)
次要结局
- Subtalar osteoarthritis(5 years)
- EQ-5D-5L(5 years)
- American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score(5 years)
- Calcaneus Fracture Scoring System (CFSS)(5 years)
- Self-reported foot and ankle score (SEFAS)(5 years)
- Visual Analogue Scale (VAS) for pain(5 years)
- Incidence of complications(5 years)
- Böhler angle(5 years)