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NCT Number: NCT07558941

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

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.

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Key information

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conservative treatment by casting

Other

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.

surgical treatment via percutaneous pinning UGA

Procedure

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 outcomes

  1. Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score

    Time frame: 1 year

    Functional outcome will be evaluated using the Modified QuickDASH questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.

Secondary outcomes

  1. Elbow flexion range of motion (degrees)

    Time frame: 1 month, 3 months, and 6 months post-intervention

    Measured in degrees using a goniometer to assess maximum elbow flexion.

  2. Elbow extension range of motion (degrees)

    Time frame: 1 month, 3 months, and 6 months post-intervention

    Measured in degrees using a goniometer to assess maximum elbow extension.

  3. Pain assessed using Visual Analog Scale (VAS)

    Time frame: 1 month, 3 months, and 6 months post-intervention

    Pain is measured on a scale from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain.

  4. Baumann angle (degrees)

    Time frame: Immediately post-reduction and at 6 months

    Measured on standard anteroposterior elbow radiographs to assess coronal alignment.

  5. Anterior humeral line alignment (normal/abnormal)

    Time frame: Immediately post-reduction and at 6 months

    Assessed on lateral elbow radiographs to evaluate sagittal alignment.

  6. Loss of reduction (yes/no)

    Time frame: Up to 6 months post-intervention

    Defined as displacement of fracture fragments on follow-up radiographs.

  7. Incidence of nerve injury (yes/no)

    Time frame: Up to 6 months post-intervention

    Includes any documented motor or sensory nerve deficit following treatment.

  8. Incidence of infection (yes/no)

    Time frame: Up to 6 months post-intervention

    Includes superficial or deep infection related to treatment.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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