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临床试验/NCT05504304
NCT05504304已完成不适用

Outcomes of Sanders Type IV Calcaneal Fractures Treated With Open Reduction and Internal Fixation (ORIF) Plus Primary Subtalar Arthrodesis (PSTA) Versus Conservative Management Then Calcaneoplasty and Late Subtalar Arthrodesis.

Ain Shams University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Foot and Ankle Ability Measure (FAAM).

研究概览

简要总结

Fracture calcaneus accounts for up to 2% of all fractures. 75% of calcaneal fractures are displaced intra-articular fractures and historically have been associated with poor functional outcomes.

When the talus applies an axial loading to the posterior facet, shear forces result in a primary fracture line between medial (sustentaculum tali) and lateral part of the calcaneus. As the axial force continues, a secondary fracture line will develop. According to the relation of the secondary fracture line's exit to insertion of tendo-achilis Essex-Lopresti classified that into two types joint depression and tongue.

Numerous classifications exist in the literature but that by Sanders is the most prevalent and best suited for clinical practice and for research purposes.

Sanders in his clinical trials found that as the number of articular fragments- based on axial and coronal CT scan cuts with the widest undersurface of the posterior facet of the talus- increase, the results and prognosis worsen.

Up to 73% in the sanders type IV fractures eventually leads to subtalar fusion to manage post-traumatic subtalar arthritis. They are 5.5 times more likely to require subtalar arthrodesis than Sanders II fractures. Second surgeries increase the cost of management and delay the return of level of function for the patient.

Some authors advocate that the fractures with a higher Sanders classification demonstrated no difference between operative and non-operative treatment. However, careful stratification of the patients may show better outcomes after surgical intervention in some groups.

There is no consensus about how to manage calcaneal fractures but we can divide management into four broad categories: Non-operative, Open reduction and internal fixation, Minimally invasive reduction and fixation and finally Primary ORIF and subtalar arthrodesis.

Our trial was conducted to add to the current evidence and our main questions are: does initial reduction and fixation of comminuted displaced intra-articular Sanders type IV calcaneal fractures matter in subtalar fusion?

详细描述

Randomization: patients presented to clinic or emergency room with recent (30 days or less) Sanders type IV intra-articular calcaneal fractures will be included in group A. Patients referred to our clinic (from other surgeons or hospitals) with old (more than three months) Sanders type IV intra-articular calcaneal fractures will form group B.

Group A: open reduction and internal fixation plus primary subtalar arthrodesis.

Group B: conservative management for at least three months then calcaneoplasty and late subtalar arthrodesis.

Ethical Considerations: Will be followed by obtaining the hospital Research Ethics Committee approval and written informed consents from the patients.

Intervention:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 59 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a Sanders IV displaced intra-articular calcaneal fracture (DIACF).
  • Within 12 months from injury.
  • Clear demonstration of at least 3 fracture lines across the posterior subtalar facet, dividing it into at least 4 fragments and the fragments being displaced by at least 2 mm, as seen on the coronal and axial CT scans (classified as Sanders IV).
  • Ability to provide informed consent.
  • Available for follow-up for at least 6 months after intervention.

排除标准

  • Medical contraindications to surgery.
  • Fracture more than 12 months old at first presentation.
  • Previous calcaneal pathology (infection, tumor etc).
  • Previous calcaneal surgery.
  • Co-existent foot or ipsilateral lower limb injury.
  • Open calcaneal fractures.
  • Inability to obtain preoperative CT scans or accurately classify the fractures as per Sanders classification system.

结局指标

主要结局

Foot and Ankle Ability Measure (FAAM).

时间窗: up to two years

functional state of the patient

time to return to work in months

时间窗: up to two years

the time from injury till resuming their jobs (if returned to job)

the American Orthopaedic Foot and Ankle Society's Ankle-Hindfoot score (AOFAS score)

时间窗: up to two years

functional state of the patient

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bishoy Emil

assistant lecturer

Ain Shams University

研究点 (2)

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