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临床试验/NCT04605341
NCT04605341Unknown不适用

Comparative Study Between Miniplate and Buried k Wires in Management of Metacarpal Fractures

Assiut University0 个研究点目标入组 50 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
主要终点
miniplate,buried k wires and union

研究概览

简要总结

To compare between buried k wires and miniplate in management of metacarpal fracture.

详细描述

Fractures of the carpals, metacarpals and phalanges account for approximately 15-19% of fractures in adults, with 59% of these occurring in the phalanges, 33% in the metacarpals and 8% in the carpal bones [1]. The single most common fracture site in the hand is the sub capital region of the fifth metacarpal bone (boxer's fracture) [2], which usually results from a direct blow to the metacarpal head [3]. Most hand fractures are caused by accidental falls or other sports-related injuries [4]. Hand fractures are among the most common fractures of upper extremity [5, 6]. Hand fractures can be treated conservatively or surgically, depending on the severity, location and type of fracture. The main objective of both operative and non-operative treatments is to provide fracture stability for early mobilization [7]. Surgical fixation is mainly indicated for displaced fractures because casts are often not sufficient to maintain reduction [8]. Open reduction with internal fixation (ORIF), using pins or plates, has historically been used to stabilize hand fractures which have rotational deformity or lateral angulation [9]. Open reduction may result in scarring, joint stiffness and tendon adhesion [7]. Closed reduction with internal fixation (CRIF), using percutaneous K wire or screws, is now used to treat the majority of unstable closed simple hand fractures [10]. It is generally considered percutaneous Kirschner wire (K wire) fixation may not provide adequate stabilization to allow for early mobilization [8] .

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
Single (Care Provider)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age: ( 20-60) years,
  • •Fresh (fixed within 3 days),
  • •Single or multiple fractures of metacarpals.

排除标准

  • •Pathological fracture,
  • •Major systemic illness, malignancy,
  • •Patient on drugs affecting fracture healing like steroid, anticancer drugs,
  • •Polytrauma patients,
  • •Extensive comminution of the metacarpal or phalanx detected pre- or intra-operatively,
  • •Dislocations at either end of the fractured bone
  • •Parents/guardians/patients not willing to participate in study.

研究组 & 干预措施

group one

Active Comparator

patient with metacarpal fracture that will use minipate for fixation

干预措施: miniplate (Device)

gruop two

Active Comparator

patient with metacarpal fracture that will use buried k wires for fixation

干预措施: miniplate (Device)

结局指标

主要结局

miniplate,buried k wires and union

时间窗: 6 month

• To compare between union and healing in metacarpal fracture fixation by miniplate versus buried intramedullary k. wires by imaging using anteroposterior and lateral and oblique views x ray to determine union and healing by seeing bridging callus in two or more cortices

次要结局

  • Range of motion(6 month)

研究者

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

mina kamal

principle investigator

Assiut University

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