- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07558941
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
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Sperimentale: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
Lasso di tempo: 1 year
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Functional outcome will be evaluated using the Modified QuickDASH questionnaire.
Scores range from 0 to 100, with higher scores indicating greater disability.
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1 year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Elbow flexion range of motion (degrees)
Lasso di tempo: 1 month, 3 months, and 6 months post-intervention
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Measured in degrees using a goniometer to assess maximum elbow flexion.
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1 month, 3 months, and 6 months post-intervention
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Elbow extension range of motion (degrees)
Lasso di tempo: 1 month, 3 months, and 6 months post-intervention
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Measured in degrees using a goniometer to assess maximum elbow extension.
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1 month, 3 months, and 6 months post-intervention
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Pain assessed using Visual Analog Scale (VAS)
Lasso di tempo: 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.
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1 month, 3 months, and 6 months post-intervention
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Baumann angle (degrees)
Lasso di tempo: Immediately post-reduction and at 6 months
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Measured on standard anteroposterior elbow radiographs to assess coronal alignment.
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Immediately post-reduction and at 6 months
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Anterior humeral line alignment (normal/abnormal)
Lasso di tempo: Immediately post-reduction and at 6 months
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Assessed on lateral elbow radiographs to evaluate sagittal alignment.
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Immediately post-reduction and at 6 months
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Loss of reduction (yes/no)
Lasso di tempo: Up to 6 months post-intervention
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Defined as displacement of fracture fragments on follow-up radiographs.
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Up to 6 months post-intervention
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Incidence of nerve injury (yes/no)
Lasso di tempo: Up to 6 months post-intervention
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Includes any documented motor or sensory nerve deficit following treatment.
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Up to 6 months post-intervention
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Incidence of infection (yes/no)
Lasso di tempo: Up to 6 months post-intervention
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Includes superficial or deep infection related to treatment.
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Up to 6 months post-intervention
|
Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Supracondyler humeral fracture
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