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临床试验/CTRI/2021/02/031279
CTRI/2021/02/031279已完成3 期

A Comparative Study Of Functional Outcome Of Intra Articular Fracture Distal End Radius Treated With Variable Angle Locking Compression Plate Versus Fixed Angle Locking Compression Plate

Aiims Raipur1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年2月27日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Functional and Radiological outcome using fixed and variable angle locking compression plate

研究概览

简要总结

Distal radius fractures are the most common fractures of upper limb presenting in the  emergency, compromising of more than 16% of all the fractures. Distal radial fractures have a bimodal type of age distribution with High-energy trauma contributing in younger and low energy trauma in Elderly population. Females are more liable to distal radius fractures when compared with males mainly because of more severe osteoporosis and a higher liability of elderly women to fall as compared to the age matched men.Consequently, a fracture of the distal  radius is typically the result of a fall on an outstretched hand in a post menopausal woman, where a functionally active person suffers a trauma on an osteoporotic bone. About 60 years ago, most distal radial fractures were treated conservatively with satisfactory results. Recently, it has been clinically proved that intra-articular step-off and radial shortening corrected by surgery have improved patient outcome.In general, anatomic reduction and stable fixation should be pursued in younger and high-demand elderly patients to initiate early mobilization. Undisplaced or reducible but stable extra and intra-articular fractures can also be treated with casting. Extra articular fractures that are irreducible, intra-articular fractures and fractures for demanding patients who require early mobilization, are commonly treated with plating (more often with Volar plating), intra medullary fixation, external fixation or pinning. Dorsal plating is rarely used due to complications like  extensor tendon rupture, tendinosis and  volar collapse.Close reduction and cast immobilization has been the principal mode of  management of distal radius fractures but it often lead  to  fracture malunion and subluxation/ dislocation of distal radio-ulnar joint, hence resulting in poor functional, radiographic and cosmetic  result.The residual deformity of wrist adversely affected wrist motion and hand function, there by interfering with the mechanical advantage of the extrinsic hand musculature.It also causes pain, limitation of forearm motion, and decreased grip strength as a result of arthrosis of the radiocarpal and distal radioulnar joints. Open reduction and volar plating was designed to ensure more consistent correction of the displacement, maintenance of reduction and to initiate early range of movement exercises. The purpose of  this study is to compare  functional and radiological outcomes of  variable angle locking compression to fixation strategies with fixed  angle volar locking compression plates.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Radiological findings confirming intra articular fracture of Distal End Radius according to AO classification ( Type 23.B1 to 23.C3) 2.Patient who are willing for surgery 3.Age group more than 18 years.

排除标准

  • 1.Patients with pathological fractures 2.Open fractures Gustilo and Anderson type II or type III 3.Fracture with neuro- vascular injury 4.Contralateral injury to wrist and carpals 5.Ipsilateral fracture of shoulder and elbow 6.Pregnant woman.

结局指标

主要结局

Functional and Radiological outcome using fixed and variable angle locking compression plate

时间窗: Patients will be followed for a period of 6 months, with one evaluation at 15 days post–surgery for suture removal and to check wound site and monthly for first 3 months and then at 6 months post-surgery.

次要结局

  • complications and other problems related to study(6 months)

研究者

发起方
Aiims Raipur
申办方类型
Research institution

研究点 (1)

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