跳至主要内容
临床试验/NCT07423507
NCT07423507尚未招募不适用

Comparative Study Between Internal Fixtion And Primary Subtalar Arthrodesis In Comminuted Intra-Articular Calcaneal Fracture

Ahmed Gamal Ibrahim Saleh0 个研究点目标入组 40 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
Orthopedic foot and ankle AOFAS

研究概览

简要总结

This study is to compare clinical outcome of Sanders type III or IV intra-articular calcaneal fracture treated with open reduction and internal fixation (ORIF) versus ORIF and primary subtalar arthrodesis (PSTA).

详细描述

The calcaneal fractures are the most common tarsal bone fracture, accounting for up to 2% of all fractures in the human body, of which approximately 75% of these fractures are intra-articular.(Almeida, Vale et al. 2022) The calcaneal fractures are serious injuries, often resulting from traumatic axial loading as falls from height or motor vehicle accidents. clinically, it manifests as swelling, pain, ecchymosis, edema of the distal extremity, and an inability to bear weight. Sometimes, anatomical deformity of the hindfoot is noted.(Giuliani, Calori et al. 2025) Radiographic classification of calcaneal fractures is essential for guiding treatment. The Essex-Lopresti classification, one of the oldest reference systems, classifies fractures into tongue type and joint depression-type based on the fracture pattern and orientation of the fracture line. This classification remains important today, particularly for determining surgical approaches and predicting complications.(Essex-Lopresti 1952) Additionally, the Sanders system, currently one of the most widely utilized classification systems for calcaneal fractures, categorizes intra-articular fractures into four types (Type I, II, III, and IV) based on the number and location of fracture lines and fragments.(Sanders 2000, Galluzzo, Greco et al. 2018) Historically, comminuted intra-articular calcaneal fractures were treated nonoperatively, as predictable operative reduction and fixation were not possible. Presently, surgical treatment through ORIF is considered the standard management.(Buckley, Tough et al. 2010, Sanders, Vaupel et al. 2014) Although ORIF has improved clinical and radiological outcomes of comminuted intra-articular calcaneal fractures, Sanders and colleagues reported that fractures involving complications after surgery, proposing primary subtalar arthrodesis (PSA) as alternative.(Eisenstein, Kusnezov et al. 2018, Maccagnano, Noia et al. 2021) Several authors advocate PSA in cases of highly comminuted fractures due to favorable functional results, The management of these fracture patterns is not well established, and the literature remains controversial.(Cianni, Vitiello et al. 2022, Giuliani, Calori et al. 2025).

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sanders type 3 and 4 intra articular calcaneal fracture within 14 day of injury

排除标准

  • patient with open injury, concomitant foot injury, vascular compromise and prior subtalar pathology

研究组 & 干预措施

Primary Subtalar Arthrodesis Group

Experimental

Patients with Sanders type III and IV intra-articular calcaneal fractures treated with primary subtalar arthrodesis using cannulated compression screws with plate fixation through an extended lateral approach.

干预措施: Primary Subtalar Arthrodesis (Procedure)

Open Reduction and Internal Fixation

Experimental

Patients undergo open reduction and internal fixation of displaced intra-articular calcaneal fractures through an extended lateral approach. Fracture reduction is achieved under fluoroscopic guidance, restoring Bohler's and Gissane's angles. Fixation is performed using a locking calcaneal plate with screws. Postoperative care includes immobilization in a cast or splint, non-weight bearing for 8 weeks, followed by a standardized physiotherapy program. This procedure is distinguished from other calcaneal fracture treatments by the use of locking plate technology and precise anatomical reduction for Sanders type III and IV fractur

干预措施: Open reduction and internal fixation (Procedure)

结局指标

主要结局

Orthopedic foot and ankle AOFAS

时间窗: 2,4,6,8,12 weeks,6 months and 1.5years after operation

Orthopedic foot and ankle score (AOFAS)

时间窗: 2'4'8'12 weeks' 6 months, and 1.5 years after surgery

次要结局

未报告次要终点

研究者

发起方
Ahmed Gamal Ibrahim Saleh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Gamal Ibrahim Saleh

A Prospective Randomized Controlled Trial Comparing ORIF with Primary Subtalar Arthrodesis Versus Open Reduction and Internal Fixation in Sanders Type III and IV Intra-Articular Calcaneal Fractures

Al-Azhar University

相似试验

Comparative Study Between Internal Fixtion And... | 临床试验