Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Which One ?
26 april 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
50
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Elbow flexion range of motion (degrees)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Immediately post-reduction and at 6 months
|
Assessed on lateral elbow radiographs to evaluate sagittal alignment.
|
Immediately post-reduction and at 6 months
|
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Loss of reduction (yes/no)
Tidsram: Up to 6 months post-intervention
|
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)
Tidsram: 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)
Tidsram: Up to 6 months post-intervention
|
Includes superficial or deep infection related to treatment.
|
Up to 6 months post-intervention
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
1 juni 2028
Avslutad studie (Beräknad)
1 augusti 2028
Studieregistreringsdatum
Först inskickad
18 april 2026
Först inskickad som uppfyllde QC-kriterierna
26 april 2026
Första postat (Faktisk)
30 april 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 april 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 april 2026
Senast verifierad
1 april 2026
Mer information
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Ytterligare relevanta MeSH-villkor
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