Vascular ComplicationsNCT07488845
Management of Vascular Complications in Pediatric Supracondylar Humerus Fractures
A study testing vascular exploration in people with Vascular Complications and Supracondylar Humerus Fracture, run by Assiut University at 1 site in Egypt.
Trial summary
To determine the incidence and types of vascular injuries associated with pediatric supracondylar humerus fractures. Identify outcomes of different management strategies Identify risk factors for vascular injury Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Vascular Complications, Supracondylar Humerus Fracture
- What is being tested?
- vascular exploration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ● Children Diagnosed with supracondylar humerus fracture (Gartland I-IV) aged under 15 years.
- Presented within 1st 48 hrs of injury.
Who cannot join
- ● Old trauma >48 hours
- Previous vascular intervention in the same limb
- Another fracture in the same limb
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hesham Elsayed Aboloyon contact
About this study
- To determine the incidence and types of vascular injuries associated with pediatric supracondylar humerus fractures.
- Identify outcomes of different management strategies
- Identify risk factors for vascular injury
Read the detailed description
Supracondylar humerus fractures are the most common elbow fractures in children. Because the brachial artery lies anterior to the distal humerus, displaced fractures can cause:
Arterial spasm, Intimal injury, Thrombosis, Entrapment or transection) Vascular injury risk increases significantly with higher Gartland classifications of supracondylar humerus fractures, peaking in Type III and Type IV injuries.
Vascular compromise can lead to ischemia, compartment syndrome, and long-term functional deficits if not promptly identified and treated.
The decision-making around "pink pulseless hand" remains controversial Some centers advocate observation after reduction, while others recommend early exploration.
- Being tested
- vascular exploration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascular explorationProcedure or surgery
Patients with no pulse or distal doppler signals, and delayed capillary refill time will undergo immediate vascular exploration and injuries will be documented and managed accordingly.
| Study group | Role | What they receive |
|---|---|---|
| Patients with intact pulse will be followed up for 48 hours after fixation | No intervention | Not described |
| Pink pulseless hand | Other | ): Patients with no pulse, but with good biphasic distal doppler signals, well perfused hand capillary refill time less than 3 seconds, and normal oxygen saturation.
Patients in this group will be managed by watchful observation for 48 hours after fixation. Vascular exploration will only be indicated if hand ischemia, loss of distal doppler signals, or deterioration of digital oxygen saturation occur Receives: Procedure: vascular exploration |
| Pale pulseless hand | Active comparator | Patients with no pulse or distal doppler signals, and delayed capillary refill time will undergo immediate vascular exploration and injuries will be documented and managed accordingly. Receives: Procedure: vascular exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of vascular complications in patients with supracondylar humerus fractures
Measured: baseline
Secondary outcomes (1)
Predictors of vascular complications in pediatric supracondylar humerus fractures.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Vascular ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Mamdouh Fakher, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488845
- Sponsor's protocol ID
- supracodylar humerus fractures
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dabis J, Daly K, Gelfer Y (2016): Supracondylar fractures of the humerus in children: a review of management and controversies. Orthopedic & Muscular System, 5(01): 1-4.
Benedetti Valentini M, Farsetti P, Martinelli O, Laurito A, Ippolito E. The value of ultrasonic diagnosis in the management of vascular complications of supracondylar fractures of the humerus in children. Bone Joint J. 2013 May;95-B(5):694-8. doi: 10.1302/0301-620X.95B5.31042.
PubMed 23632684Schoenecker PL, Delgado E, Rotman M, Sicard GA, Capelli AM. Pulseless arm in association with totally displaced supracondylar fracture. J Orthop Trauma. 1996;10(6):410-5. doi: 10.1097/00005131-199608000-00008.
PubMed 8854319Farnsworth CL, Silva PD, Mubarak SJ. Etiology of supracondylar humerus fractures. J Pediatr Orthop. 1998 Jan-Feb;18(1):38-42.
PubMed 9449099Barr LV. Paediatric supracondylar humeral fractures: epidemiology, mechanisms and incidence during school holidays. J Child Orthop. 2014 Mar;8(2):167-70. doi: 10.1007/s11832-014-0577-0. Epub 2014 Mar 19.
PubMed 24643672Cheng JC, Lam TP, Maffulli N. Epidemiological features of supracondylar fractures of the humerus in Chinese children. J Pediatr Orthop B. 2001 Jan;10(1):63-7.
PubMed 11269814Leiblein M, Lustenberger T, Schulz AK, Schmitz-Rixen T, Marzi I. Neurovascular complications after supracondylar humerus fractures in children. Trauma Case Rep. 2017 Jan 6;8:16-19. doi: 10.1016/j.tcr.2017.01.013. eCollection 2017 Apr.
PubMed 29644308. Hosam Roshdy M, Khaled El Alfy M, Hesham Sharaf M et al. (2016): Vascular Complications of Supracondylar Humeral Fractures in Pediatrics. Egyptian Journal of Vascular and Endovascular Surgery, 12: 1-5
Usman R, Jamil M, Hashmi JS. Management of Arterial Injury in Children with Supracondylar Fracture of the Humerus and a Pulseless Hand. Ann Vasc Dis. 2017 Dec 25;10(4):402-406. doi: 10.3400/avd.oa.17-00050.
PubMed 29515703Shaw BA, Kasser JR, Emans JB, Rand FF. Management of vascular injuries in displaced supracondylar humerus fractures without arteriography. J Orthop Trauma. 1990;4(1):25-9. doi: 10.1097/00005131-199003000-00004.
PubMed 2313426Garg S, Weller A, Larson AN, Fletcher ND, Kwon M, Schiller J, Browne R, Copley L, Ho C. Clinical characteristics of severe supracondylar humerus fractures in children. J Pediatr Orthop. 2014 Jan;34(1):34-9. doi: 10.1097/BPO.0b013e31829c0046.
PubMed 23812149Lebowitz C, Matzon JL. Arterial Injury in the Upper Extremity: Evaluation, Strategies, and Anticoagulation Management. Hand Clin. 2018 Feb;34(1):85-95. doi: 10.1016/j.hcl.2017.09.009.
PubMed 29169600Mohammadzadeh MA, Mohammadzadeh M, Mohammadzadeh A, Herfatkar R, Mohammadzadeh V, Baghi I, Heydari H, Najafi S, Jalili M. Arterial damage accompanying supracondylar fractures of the humerus. Trauma Mon. 2012 Jan;16(4):160-3. doi: 10.5812/kowsar.22517464.3273. Epub 2012 Jan 15.
PubMed 24749093Wu J, Perron AD, Miller MD, Powell SM, Brady WJ. Orthopedic pitfalls in the ED: pediatric supracondylar humerus fractures. Am J Emerg Med. 2002 Oct;20(6):544-50. doi: 10.1053/ajem.2002.34850.
PubMed 12369030
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Vascular Complications in Pediatric Supracondylar Humerus Fractures
- ClinicalTrials.gov ID
- NCT07488845
- Acronym / sponsor ID
- supracodylar humerus fractures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 23 Mar 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.
- To determine the incidence and types of vascular injuries associated with pediatric supracondylar humerus fractures.
- Identify outcomes of different management strategies
- Identify risk factors for vascular injury
Detailed description
Supracondylar humerus fractures are the most common elbow fractures in children. Because the brachial artery lies anterior to the distal humerus, displaced fractures can cause:
Arterial spasm, Intimal injury, Thrombosis, Entrapment or transection) Vascular injury risk increases significantly with higher Gartland classifications of supracondylar humerus fractures, peaking in Type III and Type IV injuries.
Vascular compromise can lead to ischemia, compartment syndrome, and long-term functional deficits if not promptly identified and treated.
The decision-making around "pink pulseless hand" remains controversial Some centers advocate observation after reduction, while others recommend early exploration.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with intact pulse will be followed up for 48 hours after fixation | No intervention | – |
| Pink pulseless hand | Other | Procedure: vascular exploration): Patients with no pulse, but with good biphasic distal doppler signals, well perfused hand capillary refill time less than 3 seconds, and normal oxygen saturation. Patients in this group will be managed by watchful observation for 48 hours after fixation. Vascular exploration will only be indicated if hand ischemia, loss of distal doppler signals, or deterioration of digital oxygen saturation occur |
| Pale pulseless hand | Active comparator | Procedure: vascular explorationPatients with no pulse or distal doppler signals, and delayed capillary refill time will undergo immediate vascular exploration and injuries will be documented and managed accordingly. |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ● Children Diagnosed with supracondylar humerus fracture (Gartland I-IV) aged under 15 years.
Key exclusion criteria (3 listed)
- ● Old trauma >48 hours
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 explorationPatients with no pulse or distal doppler signals, and delayed capillary refill time will undergo immediate vascular exploration and injuries will be documented and managed accordingly. | Procedure or surgery | Pale pulseless hand, Pink pulseless hand |
Primary outcome
incidence of vascular complications in patients with supracondylar humerus fractures
Time frame: baseline
1 secondary outcome
Predictors of vascular complications in pediatric supracondylar humerus fractures.
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- BackgroundDabis J, Daly K, Gelfer Y (2016): Supracondylar fractures of the humerus in children: a review of management and controversies. Orthopedic & Muscular System, 5(01): 1-4.
- Background: PubMed 23632684Benedetti Valentini M, Farsetti P, Martinelli O, Laurito A, Ippolito E. The value of ultrasonic diagnosis in the management of vascular complications of supracondylar fractures of the humerus in children. Bone Joint J. 2013 May;95-B(5):694-8. doi: 10.1302/0301-620X.95B5.31042.
- Background: PubMed 8854319Schoenecker PL, Delgado E, Rotman M, Sicard GA, Capelli AM. Pulseless arm in association with totally displaced supracondylar fracture. J Orthop Trauma. 1996;10(6):410-5. doi: 10.1097/00005131-199608000-00008.
- Background: PubMed 9449099Farnsworth CL, Silva PD, Mubarak SJ. Etiology of supracondylar humerus fractures. J Pediatr Orthop. 1998 Jan-Feb;18(1):38-42.
- Background: PubMed 24643672Barr LV. Paediatric supracondylar humeral fractures: epidemiology, mechanisms and incidence during school holidays. J Child Orthop. 2014 Mar;8(2):167-70. doi: 10.1007/s11832-014-0577-0. Epub 2014 Mar 19.
- Background: PubMed 11269814Cheng JC, Lam TP, Maffulli N. Epidemiological features of supracondylar fractures of the humerus in Chinese children. J Pediatr Orthop B. 2001 Jan;10(1):63-7.
- Background: PubMed 29644308Leiblein M, Lustenberger T, Schulz AK, Schmitz-Rixen T, Marzi I. Neurovascular complications after supracondylar humerus fractures in children. Trauma Case Rep. 2017 Jan 6;8:16-19. doi: 10.1016/j.tcr.2017.01.013. eCollection 2017 Apr.
- Background. Hosam Roshdy M, Khaled El Alfy M, Hesham Sharaf M et al. (2016): Vascular Complications of Supracondylar Humeral Fractures in Pediatrics. Egyptian Journal of Vascular and Endovascular Surgery, 12: 1-5
- Background: PubMed 29515703Usman R, Jamil M, Hashmi JS. Management of Arterial Injury in Children with Supracondylar Fracture of the Humerus and a Pulseless Hand. Ann Vasc Dis. 2017 Dec 25;10(4):402-406. doi: 10.3400/avd.oa.17-00050.
- Background: PubMed 2313426Shaw BA, Kasser JR, Emans JB, Rand FF. Management of vascular injuries in displaced supracondylar humerus fractures without arteriography. J Orthop Trauma. 1990;4(1):25-9. doi: 10.1097/00005131-199003000-00004.
- Background: PubMed 23812149Garg S, Weller A, Larson AN, Fletcher ND, Kwon M, Schiller J, Browne R, Copley L, Ho C. Clinical characteristics of severe supracondylar humerus fractures in children. J Pediatr Orthop. 2014 Jan;34(1):34-9. doi: 10.1097/BPO.0b013e31829c0046.
- Background: PubMed 29169600Lebowitz C, Matzon JL. Arterial Injury in the Upper Extremity: Evaluation, Strategies, and Anticoagulation Management. Hand Clin. 2018 Feb;34(1):85-95. doi: 10.1016/j.hcl.2017.09.009.
- Individual participant dataSharing planned: Undecided
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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.
Hesham Elsayed Aboloyon contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vascular exploration in people with Vascular Complications and Supracondylar Humerus Fracture, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mina Mamdouh Fakher (+201017243109, minamamdouhf1999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of vascular complications in patients with supracondylar humerus fractures (time frame: baseline). 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 NCT07488845, which also lists 14 linked publications.
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 23 Mar 2026.