NCT07705347尚未招募不适用
Locking Compression Mini-plate Osteosynthesis Versus Titanium Elastic Intramedullary Nailing in Management of Diaphyseal Forearm Fractures in Adolescents
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Functional outcome assessed using the Grace and Eversmann scoring system.
研究概览
简要总结
evaluate and compare the clinical, and radiographic outcomes of 2.7 mm locking compression mini-plate osteosynthesis versus titanium elastic intramedullary nail (TEN) in the surgical management of diaphyseal fractures of both forearm bones in adolescent patients
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
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 10 to 16 years (at time of injury).
- •Fracture pattern: diaphyseal fracture involving both the radius or ulna.
- •o Fracture location: Diaphysis defined as the segment between the proximal metaphyseal flare (distal to bicipital tuberosity for radius; distal to coronoid process for ulna) and the distal metaphyseal flare (within 3 cm of the distal physis).
- •Indication for surgery: Failure of closed reduction or unacceptable alignment after attempted closed reduction, defined as:
- •Angulation > 15° in any plane (sagittal or frontal).
- •Translation > 50% of bone diameter.
- •Bayonet apposition.
- •Open fracture (Gustilo type I).
- •Inability to maintain acceptable reduction after cast immobilization (loss of reduction).
- •Skeletal maturity: Open or partially open distal radial physis (assessed on preoperative radiographs).
排除标准
- •Open fracture Gustilo type II & III.
- •Pathological fracture (secondary to bone cyst, tumor, osteogenesis imperfecta, etc.).
- •Neurovascular compromise requiring emergent exploration (e.g., acute compartment syndrome, pulseless limb after reduction).
- •Floating elbow (ipsilateral supracondylar humerus fracture + forearm fracture).
- •Monteggia or Galeazzi fracture-dislocation patterns
- •Metabolic bone disease (e.g., rickets, osteomalacia, renal osteodystrophy).
- •Neuromuscular disorder affecting upper extremity function (e.g., cerebral palsy, muscular dystrophy, brachial plexus injury).
- •Active infection at surgical site or systemic infection.
结局指标
主要结局
Functional outcome assessed using the Grace and Eversmann scoring system.
时间窗: 6 months
次要结局
- Radiographic Bone Union Time(6 months)
研究者
Ramadan Moanes Ramadan
Resident
Sohag University
研究点 (1)
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