Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Which One ?
26. april 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
Tidsramme: 1 year
|
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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Elbow flexion range of motion (degrees)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. juni 2028
Studiet fullført (Antatt)
1. august 2028
Datoer for studieregistrering
Først innsendt
18. april 2026
Først innsendt som oppfylte QC-kriteriene
26. april 2026
Først lagt ut (Faktiske)
30. april 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. april 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Supracondyler humeral fracture
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