Supracondylar Humerus Fracturepulseless-pinkNCT07832058
Necessity of Vascular Surgical Intervention in Pulseless Supracondylar Fractures in Children
An observational study of Supracondylar Humerus Fracture and Vascular Trauma, run by University Hospital Hradec Kralove at 11 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 15 years
- Conditions the study is for
- Supracondylar Humerus Fracture, Vascular Trauma, Ischemia
- What is being tested?
- Vascular surgical intervention
- Type of treatment
- Surgery or procedure
- How many people
- 190 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 1 Jan 2014to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with displaced pulseless supracondylar fracture of distal humerus
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Czechia10 sites
Department of Paediatric Surgery, Orthopaedics and Traumatology, University Hospital, Masaryk University, Brno, Czech Republic
Brno
Department of traumatology, Orthopaedics department, Hospital České Budějovice
České Budějovice
University Hospital Hradec Králové
Hradec Králové, CZ, 50005
Department of Paediatric Surgery and Traumatology, University Hospital Ostrava, Faculty of Medicine Ostrava
Ostrava
Department of Pediatric Surgery, Pardubice Hospital
Pardubice
Department of Orthopaedics and Traumatology, University Hospital Plzen, Czech Republic
Pilsen
Department of Paediatric Surgery and Traumatology, University hospital Bulovka, (1st Faculty of Medicine, Charles University) Prague
Prague
Department of Pediatric and Adult Orthopaedics and Traumatology, Motol University Hospital Prague (2nd Faculty of Medicine, Charles University)
Prague
Department of Pediatric Surgery and Traumatology, Thomayer University Hospital, (3rd Faculty of Medicine, Charles University) Prague
Prague
Department of pediatric surgery and traumatology, Masaryk Hospital, Usti nad Labem
Ústí nad Labem
Slovakia1 site
Department of Pediatric Surgery, National Institute of Children's Diseases, Bratislava
Bratislava
About this study
Official title: Pulseless Supracondylar Fractures of the Distal Humerus in Children With a Focus on Examination and Assessment of the Need for Vascular Surgical Intervention.
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.
Read the detailed description
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.
- Conditions
- Supracondylar Humerus Fracture, Vascular Trauma, Ischemia
- Being tested
- Vascular surgical intervention
- Keywords
- Pediatric Trauma, Watchful Waiting, Pulseless Pink Hand, Arterial Injury, Vascular Surgical Intervention
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular surgical interventionProcedure or surgery
necessity of various type of vascular surgical intervention in pulseless supracondylar fracture of distal humerus
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Vascular surgical intervention | |
| 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. Receives: Procedure: Vascular surgical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite rate of treatment failure (clinical or ischemic complications)
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).
Measured: 1 year after injury
Secondary outcomes (2)
Kinetics of pulse restoration
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.
Measured: Time-to-event analysis of pulse restoration within the early postoperative period
Incidence of acute perioperative and early postoperative complications
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
Measured: Within 30 days post-reduction/surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Jan 2014
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supracondylar Humerus FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University Hospital, University Hospital, Motol, Masaryk Hospital Usti nad Labem, České Budějovice Hospital, University Hospital Bratislava, University Hospital Ostrava, Thomayer University Hospital, Bulovka Hospital, Hospital Pardubice, The University Hospital Plzeň
- Responsible party
- Principal investigator, Radek Štichhauer, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832058
- Sponsor's protocol ID
- 202606 I07P
- Acronym
- pulseless-pink
- Status last verified
- Jun 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication will be available upon reasonable request. Data will be shared exclusively for the purpose of academic meta-analyses or validation of the published results, following approval by the principal investigator and the institutional ethics committee.
Publications
Stichhauer R, Preis J, Planka L, Turek J, Urban J, Horak Z, Zeman J, Konecny M, Kopacek I, Hanak F, Vojta J, Chrenkova V. Strategy of pulseless pink supracondylar humerus fracture treatment in children: a comparison of two approaches. Eur J Trauma Emerg Surg. 2022 Oct;48(5):3785-3791. doi: 10.1007/s00068-021-01794-x. Epub 2021 Sep 28.
PubMed 34585254
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulseless Supracondylar Fractures of the Distal Humerus in Children With a Focus on Examination and Assessment of the Need for Vascular Surgical Intervention.
- ClinicalTrials.gov ID
- NCT07832058
- Acronym / sponsor ID
- pulseless-pink / 202606 I07P
- Conditions
- Supracondylar Humerus Fracture, Vascular Trauma, Ischemia
- Keywords
- Pediatric Trauma, Watchful Waiting, Pulseless Pink Hand, Arterial Injury, Vascular Surgical Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Collaborators
- Brno University Hospital, University Hospital, Motol, Masaryk Hospital Usti nad Labem, České Budějovice Hospital, University Hospital Bratislava, University Hospital Ostrava, Thomayer University Hospital, Bulovka Hospital, Hospital Pardubice, The University Hospital Plzeň
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Procedure: Vascular surgical interventionPatients with a well-perfused (pink) hand but an absent radial pulse immediately after closed reduction. Managed with urgent vascular surgical intervention. |
| Pulseless Pale - Vascular Revision | – | Procedure: Vascular surgical interventionPatients presenting with an ischemic (pale, cold) hand and an absent radial pulse after orthopedic reduction. Managed with urgent vascular surgical intervention. |
Who may qualify
- Ages
- 0 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with displaced pulseless supracondylar fracture of distal humerus
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular surgical interventionnecessity of various type of vascular surgical intervention in pulseless supracondylar fracture of distal humerus | Procedure or surgery | Pulseless Pale - Vascular Revision, Pulseless Pink - Vascular Revision |
Primary outcome
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: 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).
2 secondary outcomes
Kinetics of pulse restoration
Time frame: Time-to-event analysis of pulse restoration within the early postoperative period
Incidence of acute perioperative and early postoperative complications
Time frame: Within 30 days post-reduction/surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 34585254Stichhauer R, Preis J, Planka L, Turek J, Urban J, Horak Z, Zeman J, Konecny M, Kopacek I, Hanak F, Vojta J, Chrenkova V. Strategy of pulseless pink supracondylar humerus fracture treatment in children: a comparison of two approaches. Eur J Trauma Emerg Surg. 2022 Oct;48(5):3785-3791. doi: 10.1007/s00068-021-01794-x. Epub 2021 Sep 28.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication will be available upon reasonable request. Data will be shared exclusively for the purpose of academic meta-analyses or validation of the published results, following approval by the principal investigator and the institutional ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supracondylar Humerus Fracture and Vascular Trauma, run by University Hospital Hradec Kralove at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Czechia, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite rate of treatment failure (clinical or ischemic complications) (time frame: 1 year after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07832058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.