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临床试验/NCT03639272
NCT03639272已完成不适用

Long-term Radiographic and Clinical-functional Outcomes of Isolated, Displaced, Closed Talar Neck and Body Fractures Treated by Open Reduction Iternal Fixation: the Timing of Surgical Management.

University of Padova0 个研究点目标入组 40 人开始时间: 2007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
40
主要终点
Evaluation of the development of post-injury peritalar osteoarthritis

研究概览

简要总结

The main purpose of this retrospective case series study was to evaluate long-term radiographic and clinical outcomes of a consecutive series of patients with diagnosis of isolated, displaced, closed talar neck or body fractures treated by open reduction and internal fixation. Secondly, it was aimed to verify the influence of the location of talar fractures on the outcomes, the prognostic value of the Hawkins sign, whether operative delays promote avascular necrosis (AVN) and if the fractures require emergent surgical management.

详细描述

From January 2007 to December 2012, 31 patients underwent ORIF by screws at our institution. On the basis of Inokuchi criteria, the injuries were divided between neck and body fractures, which were classified according to Hawkins and Sneppen, respectively. The patients included were divided into two groups in relation to fracture location and complexity. Radiographic assessment focused on reduction quality, bone healing, Hawkins sign and osteoarthritis development. For clinical evaluation, clinical-functional scores (AOFAS Ankle-Hindfoot Score; MFS; FFI-17; SF-36) and VAS were determined, and statistical analysis was performed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of a closed, isolated, displaced talar neck or body fracture with 2 or more millimetres displacement, subsequently treated by ORIF
  • age between 18 and 85 years
  • informed consent to participate.

排除标准

  • undisplaced fractures or involvement of both the neck and the body,
  • open fractures, talar head and peripheral fractures including posterior process, osteochondral fractures, primary arthrodesis or amputation,
  • history of severe neurological deficit,
  • previous foot surgery or trauma,
  • diagnosis of rheumathological diseases or psoriatic arthritis, foot neuropathy, severe vascular insufficiency and alcohol or drug abuse.

结局指标

主要结局

Evaluation of the development of post-injury peritalar osteoarthritis

时间窗: at last follow-up (seven years)

Post-injury peritalar osteoarthritis was evaluated on X-ray and differentiated between necrosis without collapse (sclerosis with and without geodes) and necrosis with collapse of the talar dome at the last follow-up

Evaluation of osteonecrosis

时间窗: at 6-8 weeks after injury

The Hawkins sign appearance (only on the A/P X-ray), which resembles a subchondral atrophy in the talus dome, was evaluated indicating that the talus is well vascularized. On the contrary, its absence at this time suggests the presence of osteonecrosis

Evaluation of the quality reduction after surgery

时间窗: at day 1 after surgery

Radiographic examination of anteroposterior, lateral and oblique view radiographs enabled to evaluate the quality of the reduction. Any offset of more than 2 mm or neck angulation of more than 5° between the fragment was labelled as a poor reduction.

Evaluation of bone healing

时间窗: at different follow-ups (1 month, 3 months, 6 months, 12 months, 24 months)

Criteria to define bone healing and union: The bridging bone/callus formation was evaluated on radiographs The absence of radiolucent lines was verified at different follow-ups.

次要结局

  • American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score(at last follow-up (seven years))
  • the Maryland Foot Score (MFS)(at last follow-up (seven years))
  • the 17-Foot Functional Index (FFI-17)(at last follow-up (seven years))

研究者

发起方
University of Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Biz

Orthopedic surgeon, Assistant Professor

University of Padova

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