Management of Vascular Complications in Pediatric Supracondylar Humerus Fractures

NCT07488845 | Not Yet Recruiting

• 1 other identifier: supracodylar humerus fractures
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vascular Complications; Supracondylar Humerus Fracture

Outcome Measures

Primary Outcomes (1)

• incidence of vascular complications in patients with supracondylar humerus fractures

  baseline

Secondary Outcomes (1)

• Predictors of vascular complications in pediatric supracondylar humerus fractures.

  baseline

Study Arms (3)

Patients with intact pulse will be followed up for 48 hours after fixation

NO INTERVENTION

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

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.

Procedure: vascular exploration

Interventions

vascular exploration PROCEDURE

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.

Pale pulseless hand; Pink pulseless hand

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ● Children Diagnosed with supracondylar humerus fracture (Gartland I-IV) aged under 15 years.
• Presented within 1st 48 hrs of injury.

You may not qualify if:

• ● Old trauma \>48 hours
• Previous vascular intervention in the same limb
• Another fracture in the same limb

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (14)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• Farnsworth C, Silva P, Mubarak S (1998): Etiology of supracondylar humerus fractures. Journal of Pediatric Orthopaedics, 18(1): 38-42.

  BACKGROUND

• . Barr L (2014): Pediatric supracondylar humeral fractures: Epidemiology, mechanisms, and incidence during school holidays. Journal of Children's Orthopedics, 8:167-170

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  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

• 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.

  BACKGROUND

• 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

  BACKGROUND

• . 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.

  BACKGROUND

• Lebowitz C, Matzon J (2018): Arterial injury in the upper extremity: evaluation, strategies, and anticoagulation management. Hand Clinics, 34(1): 85-95.

  BACKGROUND

• Mohammadzadeh M, Mohammadzadeh M, Mohammadzadeh A et al. (2012): Arterial damage accompanying supracondylar fractures of the humerus. Trauma Monthly, 16(4): 160-165

  BACKGROUND

• 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.

  BACKGROUND

Central Study Contacts

Mina Mamdouh Fakher

CONTACT

+201017243109; minamamdouhf1999@gmail.com

Hesham Elsayed Aboloyon

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

EG (1)