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临床试验/NCT07832058
NCT07832058已完成不适用

Pulseless Supracondylar Fractures of the Distal Humerus in Children With a Focus on Examination and Assessment of the Need for Vascular Surgical Intervention.

University Hospital Hradec Kralove11 个研究点 分布在 2 个国家目标入组 190 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
190
试验地点
11
主要终点
Composite rate of treatment failure (clinical or ischemic complications)

研究概览

简要总结

The main idea of the study is to evaluate and compare procedures and results in the treatment of pulseless supracondylar fractures in specialized pediatric surgery and traumatology departments.

详细描述

Background Supracondylar fractures of the distal humerus are common and potentially severe injuries in pediatric trauma. These fractures can be complicated by impaired vascular supply, with vascular compromise reported in 10-25% of grossly displaced cases. The injury to the brachial artery may occur via traction, external compression (swelling, bony displacement), or direct rupture by bone fragments, leading to diminished or absent pulsation in peripheral arteries (radial and ulnar), accompanied by alterations in skin temperature, color, and capillary refill.

Clinically, patients with absent radial pulses are categorized into two distinct presentations. The "pulseless pink" hand lacks a palpable radial pulse but remains warm and well-perfused with adequate capillary refill. Conversely, the "pulseless pale" hand presents with absent pulses, coldness, and overt signs of ischemia. While immediate anatomical reduction and fixation are universally indicated for both types, the subsequent vascular management-particularly for the "pulseless pink" presentation post-reduction-remains highly controversial. While some authors advocate for routine vascular exploration, others recommend an expectant approach unless frank ischemia develops.

Objectives The primary objective of this study is to evaluate the long-term clinical outcomes and safety of watchful waiting versus vascular surgical revision in patients with pulseless supracondylar fractures. The study aims to statistically confirm that a conservative approach in a well-perfused limb does not lead to an increased risk of long-term ischemic or growth-related complications.

Study Design and Methodology This is an observational, retrospective analysis of a large multicenter cohort incorporating data from 11 pediatric surgery and traumatology centers in the Czech Republic and Slovakia (2014-2024). Methodologically, the study integrates a historical retrospective cohort (2014-2018) with data extracted from prospectively maintained routine clinical registries (2019-2024).

The inclusion criteria comprise patients aged 0-15 years presenting with displaced supracondylar humerus fractures complicated by vascular compromise. The critical vascular assessment (pink vs. pale) determining cohort allocation is defined strictly after the closed reduction and K-wire fixation. Analyzed core variables obtained from routine medical records include demographics, injury parameters, Gartland classification, immediate post-reduction perfusion and neurological status, and surgical timing. Long-term clinical success is evaluated primarily using Flynn's criteria alongside the incidence of late ischemic complications (e.g., cold intolerance, claudication, growth arrest). The minimum required follow-up period for inclusion in the primary outcome analysis is 12 months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
0 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 0 to 15 years at the time of injury.
  • Isolated displaced supracondylar fracture of the distal humerus (Gartland type II or III).
  • Absence of a palpable radial pulse documented immediately after closed reduction and K-wire fixation.
  • Minimum documented clinical follow-up of 12 months.

排除标准

  • Patients who regained a palpable radial pulse immediately after orthopedic reduction.
  • Pathological fractures or fractures associated with systemic connective tissue disorders.
  • Incomplete medical records preventing the assessment of the primary outcome at 1 year.
  • Open supracondylar fractures of the distal humerus.
  • Other associated injuries of the upper extremity.

研究组 & 干预措施

Pulseless Pink - Watchful Waiting

Patients with a well-perfused (pink) hand but an absent radial pulse immediately after closed reduction and K-wire fixation. Managed conservatively (watchful waiting) without vascular exploration.

Pulseless Pink - Vascular Revision

Patients with a well-perfused (pink) hand but an absent radial pulse immediately after closed reduction. Managed with urgent vascular surgical intervention.

干预措施: Vascular surgical intervention (Procedure)

Pulseless Pale - Vascular Revision

Patients presenting with an ischemic (pale, cold) hand and an absent radial pulse after orthopedic reduction. Managed with urgent vascular surgical intervention.

干预措施: Vascular surgical intervention (Procedure)

结局指标

主要结局

Composite rate of treatment failure (clinical or ischemic complications)

时间窗: 1 year after injury

Treatment failure is defined as a composite binary endpoint. An event (failure) is recorded if the patient presents with EITHER: 1. An unsatisfactory clinical result defined by Flynn's criteria as 'Fair' or 'Poor' (loss of motion or carrying angle alteration \> 10 degrees) AND/OR 2. The presence of any chronic ischemic complication (cold intolerance, claudication, muscle hypotrophy, or growth arrest).

次要结局

  • Kinetics of pulse restoration(Time-to-event analysis of pulse restoration within the early postoperative period)
  • Incidence of acute perioperative and early postoperative complications(Within 30 days post-reduction/surgery.)

研究者

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

Radek Štichhauer

MUDr. Radek Štichhauer, Ph.D.

University Hospital Hradec Kralove

研究点 (11)

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