Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Which One ?

Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Randomized Controlled Trial

The primary aim of this research is to compare the efficacy of conservative treatment versus surgical treatment for Gartland type II supracondylar humerus fractures in children. The comparison focuses on assessing differences in clinical outcomes functional recovery times, and complication rates between the two treatment groups.

Study Overview

• Status: Not yet recruiting
• Conditions: Humeral Fractures
• Intervention / Treatment: Other: Conservative treatment by casting; Procedure: surgical treatment via percutaneous pinning UGA

Detailed Description

Supracondylar Humerus Fractures are the most common type of elbow fracture in children, typically occurring between the ages of five and seven. These injuries are critical due to their proximity to major neurovascular structures, making prompt and appropriate management essential to prevent severe complications. The vast majority (approximately 98%) of SCHFs are extension-type injuries, resulting from a fall onto an outstretched hand with the elbow hyperextended.

Classification: The Gartland System The classification is based on the degree of displacement of the distal fragment relative to the proximal fragment, as seen on a lateral radiograph.

Type I stable, nondisplaced fractures are managed non-operatively.

• Treatment: Immobilization in a long-arm cast or splint for 3 to 4 weeks, typically in 90 degrees of flexion, followed by early mobilization .
• Goal: Pain control and protection from further displacement. Type II FracturesThese fractures are unstable in extension but maintain some stability due to the intact posterior cortex. Management remains a point of controversy, with both conservative and surgical options being utilized.•Conservative Option: Closed reduction (CR) and casting, often reserved for less displaced or stable Type IIA fractures.•Surgical Option: Closed Reduction and Percutaneous Pinning (CRPP) is the preferred surgical method, especially for unstable Type IIB fractures (those with rotational instability).

Type III and IV are highly unstable fractures that require urgent intervention to achieve and maintain reduction .

Treatment: Closed Reduction and Percutaneous Pinning (CRPP) is the mainstay of treatment .Open reduction may be necessary if closed reduction fails or if there is a vascular compromise requiring exploration.

•Goal: Anatomical reduction and stable fixation to prevent malunion and neurovascular complications.

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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients with Gartland type II supracondylar humerus fractures with age between 1-12 years old treated at the AUH

Exclusion Criteria:

• Gartland Type I, III, or IV fractures.
• Open fractures.
• Associated neurovascular injury (e.g., absent radial pulse, documented nerve palsy).
• Patients with another injury in the same limb
• Pathological fractures.
• Pre-existing elbow pathology or congenital deformity.
• Inability to comply with follow-up protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conservative treatment; Children with Gartland type II supracondylar humeral fractures will be treated conservatively using closed reduction followed by immobilization in an above-elbow cast . Patients will be followed up clinically and radiologically at regular intervals to assess fracture alignment, healing, and functional outcomes.	Other: Conservative treatment by casting; Closed reduction of Gartland type II supracondylar humeral fracture under appropriate analgesia or anesthesia, followed by immobilization using an above-elbow cast. Patients will undergo regular clinical and radiographic follow-up to monitor fracture alignment, healing, and functional recovery.
Experimental: Surgical treatment group; Children will undergo surgical treatment via Closed reduction and percutaneous pinning under general anesthesia. Postoperative follow-up will include clinical and radiological assessment of fracture healing, alignment, and complications.	Procedure: surgical treatment via percutaneous pinning UGA; surgical treatment vis Closed reduction and percutaneous pinning under general anesthesia. Postoperative care includes clinical and radiographic follow-up to assess fracture healing, alignment, and potential complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score	Functional outcome will be evaluated using the Modified QuickDASH questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elbow flexion range of motion (degrees)	Measured in degrees using a goniometer to assess maximum elbow flexion.	1 month, 3 months, and 6 months post-intervention
Elbow extension range of motion (degrees)	Measured in degrees using a goniometer to assess maximum elbow extension.	1 month, 3 months, and 6 months post-intervention
Pain assessed using Visual Analog Scale (VAS)	Pain is measured on a scale from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain.	1 month, 3 months, and 6 months post-intervention
Baumann angle (degrees)	Measured on standard anteroposterior elbow radiographs to assess coronal alignment.	Immediately post-reduction and at 6 months
Anterior humeral line alignment (normal/abnormal)	Assessed on lateral elbow radiographs to evaluate sagittal alignment.	Immediately post-reduction and at 6 months
Loss of reduction (yes/no)	Defined as displacement of fracture fragments on follow-up radiographs.	Up to 6 months post-intervention
Incidence of nerve injury (yes/no)	Includes any documented motor or sensory nerve deficit following treatment.	Up to 6 months post-intervention
Incidence of infection (yes/no)	Includes superficial or deep infection related to treatment.	Up to 6 months post-intervention

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: April 18, 2026
• First Submitted That Met QC Criteria: April 26, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Arm Injuries; Humeral Fractures
• Other Study ID Numbers: Supracondyler humeral fracture

Drug and device information, study documents

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