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Not yet recruiting NCT07558941

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

No phase Interventional Humeral Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conservative treatment by casting, surgical treatment via percutaneous pinning UGA.
Who it may be relevant to
Registry conditions: Humeral Fractures. Basic parameters: 1 year — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score [Time frame: 1 year]
Secondary outcome measures (8)
  • Elbow flexion range of motion (degrees) [Time frame: 1 month, 3 months, and 6 months post-intervention]
  • Elbow extension range of motion (degrees) [Time frame: 1 month, 3 months, and 6 months post-intervention]
  • Pain assessed using Visual Analog Scale (VAS) [Time frame: 1 month, 3 months, and 6 months post-intervention]
  • Baumann angle (degrees) [Time frame: Immediately post-reduction and at 6 months]
  • Anterior humeral line alignment (normal/abnormal) [Time frame: Immediately post-reduction and at 6 months]
  • Loss of reduction (yes/no) [Time frame: Up to 6 months post-intervention]
  • Incidence of nerve injury (yes/no) [Time frame: Up to 6 months post-intervention]
  • Incidence of infection (yes/no) [Time frame: Up to 6 months post-intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07558941 · Supracondyler humeral fracture

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗