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NCT Number: NCT07832058

Necessity of Vascular Surgical Intervention in Pulseless Supracondylar Fractures in Children

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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Key information

Age range

0 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Hradec Králové, Hradec Králové, CZ, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Vascular surgical intervention

Procedure

necessity of various type of vascular surgical intervention in pulseless supracondylar fracture of distal humerus

Primary outcomes

  1. Composite rate of treatment failure (clinical or ischemic complications)

    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:

    • An unsatisfactory clinical result defined by Flynn's criteria as 'Fair' or 'Poor' (loss of motion or carrying angle alteration > 10 degrees) AND/OR
    • The presence of any chronic ischemic complication (cold intolerance, claudication, muscle hypotrophy, or growth arrest).

Secondary outcomes

  1. Kinetics of pulse restoration

    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.

  2. Incidence of acute perioperative and early postoperative complications

    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

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Collaborators

  • Brno University Hospital
  • Bulovka Hospital
  • Hospital Pardubice
  • Masaryk Hospital Usti nad Labem
  • The University Hospital Plzeň
  • Thomayer University Hospital
  • University Hospital Bratislava
  • University Hospital Ostrava
  • University Hospital, Motol
  • České Budějovice Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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