Management of Vascular Complications in Pediatric Supracondylar Humerus Fractures

• 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

Study Overview

• Status: Not yet recruiting
• Conditions: Supracondylar Humerus Fracture; Vascular Complications
• Intervention / Treatment: Procedure: vascular exploration

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mina Mamdouh Fakher; Phone Number: +201017243109; Email: minamamdouhf1999@gmail.com
• Study Contact Backup: Name: Hesham Elsayed Aboloyon

Study Locations

• Egypt
  • Asyut, Egypt
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ● Children Diagnosed with supracondylar humerus fracture (Gartland I-IV) aged under 15 years.

  • Presented within 1st 48 hrs of injury.

Exclusion Criteria:

• ● Old trauma >48 hours

  • Previous vascular intervention in the same limb
  • Another fracture in the same limb

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Patients with intact pulse will be followed up for 48 hours after fixation
Other: Pink pulseless hand; ): 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	Procedure: vascular exploration; 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.
Active Comparator: Pale pulseless hand; 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.	Procedure: vascular exploration; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of vascular complications in patients with supracondylar humerus fractures	baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Predictors of vascular complications in pediatric supracondylar humerus fractures.	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General 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 et al. (2013): The value of ultrasonic diagnosis in the management of vascular complications of supracondylar fractures of the humerus in children. The Bone & Joint Journal, 95(5): 694-698.
• Schoenecker P, Delgado E, Rotman M et al. (1996): Pulseless arm in association with totally displaced supracondylar fracture. Journal of Orthopaedic Trauma, 10(6): 410-415
• Farnsworth C, Silva P, Mubarak S (1998): Etiology of supracondylar humerus fractures. Journal of Pediatric Orthopaedics, 18(1): 38-42.
• . Barr L (2014): Pediatric supracondylar humeral fractures: Epidemiology, mechanisms, and incidence during school holidays. Journal of Children's Orthopedics, 8:167-170
• Cheng J, Lam T, Maffulli N (2001): Epidemiological features of supracondylar fractures of the humerus in Chinese children. Journal of Pediatric Orthopedics, 10(1): 63-67.
• Leiblein, M., Weber, C., Marzi, I., Barker, J.H. and Nau, C., 2017. Neurovascular complications after supracondylar humerus fractures in children. Trauma Case Reports, 8, pp.16-19. https://doi.org/10.1016/j.tcr.2017.02.001.
• . 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 J (2017): Management of arterial injury in children with supracondylar fracture of the humerus and a pulseless hand. Annals of Vascular Diseases, 10(4): 402-406.
• Shaw B, Kasser J, Emans J et al. (1990): Management of vascular injuries in displaced supracondylar humerus fractures without arteriography. Journal of Orthopaedic Trauma, 4(1): 25-29
• . Garg S, Weller A, Larson A et al. (2014): Clinical characteristics of severe supracondylar humerus fractures in children. Journal of Pediatric Orthopaedics, 34(1): 34- 39.
• Lebowitz C, Matzon J (2018): Arterial injury in the upper extremity: evaluation, strategies, and anticoagulation management. Hand Clinics, 34(1): 85-95.
• Mohammadzadeh M, Mohammadzadeh M, Mohammadzadeh A et al. (2012): Arterial damage accompanying supracondylar fractures of the humerus. Trauma Monthly, 16(4): 160-165
• Wu J, Perron A, Miller M et al. (2002): Orthopedic pitfalls in the ED: pediatric supracondylar humerus fractures. The American Journal of Emergency Medicine, 20(6): 544-550.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 7, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: supracodylar humerus fractures

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No