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

26 de abril de 2026 actualizado por: Ebraheem Ahmed Farouk Abdelraheem, Assiut University

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
Periodo de tiempo: 1 year
Functional outcome will be evaluated using the Modified QuickDASH questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.
1 year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Elbow flexion range of motion (degrees)
Periodo de tiempo: 1 month, 3 months, and 6 months post-intervention
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)
Periodo de tiempo: 1 month, 3 months, and 6 months post-intervention
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)
Periodo de tiempo: 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.
1 month, 3 months, and 6 months post-intervention
Baumann angle (degrees)
Periodo de tiempo: Immediately post-reduction and at 6 months
Measured on standard anteroposterior elbow radiographs to assess coronal alignment.
Immediately post-reduction and at 6 months
Anterior humeral line alignment (normal/abnormal)
Periodo de tiempo: Immediately post-reduction and at 6 months
Assessed on lateral elbow radiographs to evaluate sagittal alignment.
Immediately post-reduction and at 6 months
Loss of reduction (yes/no)
Periodo de tiempo: Up to 6 months post-intervention
Defined as displacement of fracture fragments on follow-up radiographs.
Up to 6 months post-intervention
Incidence of nerve injury (yes/no)
Periodo de tiempo: Up to 6 months post-intervention
Includes any documented motor or sensory nerve deficit following treatment.
Up to 6 months post-intervention
Incidence of infection (yes/no)
Periodo de tiempo: Up to 6 months post-intervention
Includes superficial or deep infection related to treatment.
Up to 6 months post-intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de junio de 2028

Finalización del estudio (Estimado)

1 de agosto de 2028

Fechas de registro del estudio

Enviado por primera vez

18 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de abril de 2026

Publicado por primera vez (Actual)

30 de abril de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de abril de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Supracondyler humeral fracture

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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