- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
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.
|
Up to 6 months post-intervention
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Supracondyler humeral fracture
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