Vascular surgical intervention
Procedurenecessity of various type of vascular surgical intervention in pulseless supracondylar fracture of distal humerus
NCT Number: NCT07832058
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.
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Notify Me0 year–15 year
All sexes
Observational
University Hospital Hradec Králové, Hradec Králové, CZ, Czechia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
necessity of various type of vascular surgical intervention in pulseless supracondylar fracture of distal humerus
Time frame: 1 year after injury
Treatment failure is defined as a composite binary endpoint. An event (failure) is recorded if the patient presents with EITHER:
Time frame: Time-to-event analysis of pulse restoration within the early postoperative period
The time elapsed from the initial orthopedic reduction until the spontaneous return of a palpable radial pulse, evaluated using Kaplan-Meier survival analysis and Log-rank test.
Time frame: Within 30 days post-reduction/surgery.
The total rate of acute complications recorded during the initial hospitalization and early follow-up. This includes acute compartment syndrome requiring fasciotomy, new or worsening neurological deficits (iatrogenic nerve injury), and early surgical site or pin-site infections requiring antibiotic therapy or surgical revision
University Hospital Hradec Kralove
Other
Pulseless Supracondylar Fractures of the Distal Humerus in Children With a Focus on Examination and Assessment of the Need for Vascular Surgical Intervention.
Acronym: pulseless-pink
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