Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Radiological union
研究概览
简要总结
Although isolated fixation methods, such as intramedullary nails or plate fixation, are commonly employed, certain fracture patterns-particularly comminuted, osteoporotic, or unstable fractures- represent a challenge to achieve stable fixation and restoring normal anatomy .
Dual fixation, combining an intramedullary nail with a low-profile 2.7-mm mini locked plate, aims to capitalize on the strengths of both techniques-a concept known as "orthogonal or hybrid stabilization". This combined approach provides enhanced biomechanical stability, allows for early mobilization by sharing the mechanical load, and minimizes the risk of non-union or hardware failure. Studying the clinical and radiological outcomes of this dual fixation strategy is essential to establish its efficacy and safety in managing complex distal ulna fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Displaced distal ulna fractures either isolated or with associated distal radius fractures.
- •Unstable distal ulna fractures
- •Age group: [Adults aged 18 years and older].
排除标准
- •Open fractures with severe soft tissue injury (Gustilo type III).
- •Pathological fractures.
- •Patients with systemic conditions affecting bone healing e.g. uncontrolled diabetes and severe osteoporosis.
研究组 & 干预措施
Distal ulna fractures
干预措施: Dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm (Procedure)
结局指标
主要结局
Radiological union
时间窗: 24 Weeks
Number of patients achieving complete bone healing as assessed by serial X-rays (presence of bridging callus on 3 out of 4 cortices). Unit of Measure: Number of Participants.
次要结局
- Mean Hand Grip Strength(24 weeks)
- Range of Motion (ROM) of the affected joint (wrist)(24 weeks)
研究者
Mostafa Ali Hamed
Senior Resident , Orthopaedics and Traumatology Department
Sohag University