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临床试验/NCT06521606
NCT06521606已完成不适用

Comparison of Temporary External Fixation and Open Reduction With Internal Fixation for the Management of Pilon Fracture: A Prospective Clinical Trial.

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Primary open reduction and internal fixation

研究概览

简要总结

Pilon fractures are among the difficult injuries to treat in orthopedic surgery. Treatment approaches should consider associated soft tissue injuries. The two main treatment modalities are a two-stage procedure (secondary open reduction internal fixation (ORIF) and primary external fixation) and one-stage ORIF. The latter is widely agreed upon in the literature. In the present study, we contrasted the outcomes of these two approaches.

详细描述

Pilon fractures are responsible for 1% of lower limb fractures and 5-7% of tibial fractures. The optimal treatment for these fractures has remained challenging and complicated despite significant advancements in recent years in the management of these fractures, mostly because of severely injured soft tissue, severe edema, and a high-energy fracture pattern. As a result, selecting an appropriate course of treatment is still debatable.

Early after the injury, the subcutaneous soft tissue and local skin condition determine whether a direct method and open reconstruction of the articular surface are safe. Early surgical treatment through a flimsy soft tissue envelope raises the possibility of wound complications, promotes infection, and may even result in limb amputation.

The idea of postponing the ultimate osteosynthesis till after the cutaneous condition has been improved came to the forefront in the 1990s. Adopted techniques stressed thorough soft-tissue care in conjunction with delayed definitive fixation to minimize additional damage to surrounding soft tissues. Both long- and short-term outcomes showed decreased surgical complications.

Pilon fractures result from two different force types that can either act individually or concurrently. The primary force is axial compression, resulting in the talus being driven into the tibial plafond; this frequently results in concomitant damage to the talar dome. The secondary force type is rotation, producing variable degrees of articular shearing and fracture fragment displacement. A clear distinction should be made between these two different forces because the relative contribution of each affects the severity of the fracture, soft tissue damage, and prognosis.

The medial fragment, which comprises the medial malleolus and the nearby weight-bearing segment, the Chaput or anterolateral fragment, and the Volkman or posterolateral fragment, typically with their ligamentous attachments intact, are the three variable yet predictable fragments that make up the most specific fracture pattern. Where the implant will be put and, eventually, the surgical approach(es) that will be employed is influenced by the position of the articular segments, the location of the fracture lines as they exit the cortex, and whether or not those parts are continuous with the intact tibial shaft.

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 (Participant)

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

入选标准

  • Age cohort: adults older than 18 years and less than
  • Sex: both sexes
  • Pilon fracture.

排除标准

  • Patients refused to join the study after explaining the risks and benefits.
  • Infected cases.
  • History of peripheral angiopathy and/or neuropathy in the injured leg.
  • Patients with open fractures.
  • Patients with compartment syndrome.
  • Patients with pathological fractures and associated knee ligament tears.

结局指标

主要结局

Primary open reduction and internal fixation

时间窗: 6 months

The scale includes nine items that can be divided into three subscales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. Function consists of seven items with a maximal score of 50 points, indicating full function. Alignment consists of one item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments. In the original publication, the AOFAS Ankle-Hindfoot Score was described to be used for ankle replacement, ankle arthrodesis, ankle instability operations, subtalar arthrodesis, subtalar instability operations, talonavicular arthrodesis, calcaneocuboid arthrodesis, calcaneal osteotomy, calcaneus fracture, talus fracture and ankle fractures

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Omar Sabry

Dr.

Kasr El Aini Hospital

研究点 (2)

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