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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07558941
Enrollment
50
Registered
2026-04-30
Start date
2026-06-01
Completion date
2028-08-01
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Humeral Fractures

Brief summary

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.

Detailed description

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.

Interventions

OTHERConservative treatment by casting

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.

PROCEDUREsurgical treatment via percutaneous pinning UGA

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score1 yearFunctional outcome will be evaluated using the Modified QuickDASH questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.

Secondary

MeasureTime frameDescription
Elbow flexion range of motion (degrees)1 month, 3 months, and 6 months post-interventionMeasured in degrees using a goniometer to assess maximum elbow flexion.
Elbow extension range of motion (degrees)1 month, 3 months, and 6 months post-interventionMeasured in degrees using a goniometer to assess maximum elbow extension.
Pain assessed using Visual Analog Scale (VAS)1 month, 3 months, and 6 months post-interventionPain is measured on a scale from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain.
Baumann angle (degrees)Immediately post-reduction and at 6 monthsMeasured on standard anteroposterior elbow radiographs to assess coronal alignment.
Anterior humeral line alignment (normal/abnormal)Immediately post-reduction and at 6 monthsAssessed on lateral elbow radiographs to evaluate sagittal alignment.
Loss of reduction (yes/no)Up to 6 months post-interventionDefined as displacement of fracture fragments on follow-up radiographs.
Incidence of nerve injury (yes/no)Up to 6 months post-interventionIncludes any documented motor or sensory nerve deficit following treatment.
Incidence of infection (yes/no)Up to 6 months post-interventionIncludes superficial or deep infection related to treatment.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026