Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Gartland type II supracondylar humerus fractures with age between 1-12 years old treated at the AUH
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Conservative treatment by casting (Other)
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.
干预措施: surgical treatment via percutaneous pinning UGA (Procedure)
结局指标
主要结局
Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
时间窗: 1 year
Functional outcome will be evaluated using the Modified QuickDASH questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.
次要结局
- Elbow flexion range of motion (degrees)(1 month, 3 months, and 6 months post-intervention)
- Elbow extension range of motion (degrees)(1 month, 3 months, and 6 months post-intervention)
- Pain assessed using Visual Analog Scale (VAS)(1 month, 3 months, and 6 months post-intervention)
- Baumann angle (degrees)(Immediately post-reduction and at 6 months)
- Anterior humeral line alignment (normal/abnormal)(Immediately post-reduction and at 6 months)
- Loss of reduction (yes/no)(Up to 6 months post-intervention)
- Incidence of nerve injury (yes/no)(Up to 6 months post-intervention)
- Incidence of infection (yes/no)(Up to 6 months post-intervention)
研究者
Ebraheem Ahmed Farouk Abdelraheem
Resident doctor at orthopedic department
Assiut University
