跳至主要内容
临床试验/NCT07440251
NCT07440251招募中不适用

Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm

Sohag University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年2月20日最近更新:
适应症
干预措施

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

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

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Ali Hamed

Senior Resident , Orthopaedics and Traumatology Department

Sohag University

研究点 (1)

Loading locations...

相似试验