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临床试验/CTRI/2022/04/041826
CTRI/2022/04/041826已完成3 期

To evaluate the outcome of management of displaced clavicular fractures using precontoured clavicular plates

Pt BD Sharma PGIMS Rohtak1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年1月5日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Radiological

研究概览

简要总结

  1. In the present study, a majority of the patients were in the younger age group with an

overall range of 18-62 years and a mean of 36 years. This pattern was found to be

statistically significant (p < 0.01).

  1. Road traffic accidents were observed to be the most common mode of injury.

  2. There were 20 cases of Robinson type 2B1, 3 cases of type 2B2 and 4 cases of type

3B1. All the cases were managed using 3.5 mm precontoured clavicular LCPs.

Lateral extension plates were used in three cases where ligamentous instability was

suspected in the lateral third of the clavicle.

  1. In the present study, 25 cases achieved radiological union with a mean healing time

of 13.8 weeks. Around 58% of the subjects were smokers. It was observed that

smoking led to a significantly longer mean healing time (110 days) than that of non-

smokers (83 days) with a p-value less than 0.01.

  1. Almost 85% of the cases did not have any complications. One patient was operated

on for bilateral clavicle fracture with 3.5 mm precontoured LCP but the patient had

implant failure on both sides and was subsequently lost to follow-up. Out of the

remaining 25 cases, only one had plate irritation while another had a prominent post-

operative scar. Further, it is recommended to use a depth stop to prevent inadvertent

injury to surrounding vital structures.

  1. On the assessment of functional outcomes, all the patients had excellent outcomes at

the end of six months. Further, early weight lifting with the affected limb must be

strictly avoided to prevent early fixation failure.

  1. It can be concluded that using 3.5 mm precontoured clavicular LCPs is a useful

technique that can give good functional outcomes in displaced clavicular fractures.

However, a large study with a longer follow-up is desirable to conclude it

emphatically.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •All clavicular fractures with the following features: Displacement > 2 cm Shortening > 2 cm Comminution (> 3 fragments) Segmental fractures Obvious clinical deformity Floating shoulder Fractures with skin tethering or soft tissue interposition Fractures involving neurovascular compromise Old fractures with nonunion.

排除标准

  • •All clavicle fractures which are: Pathological fractures Undisplaced fractures Age < 18 years.

结局指标

主要结局

Radiological

时间窗: Radiological | features of union shall be looked for, such as, gradual disappearance of fracture line and | cortical continuity in 1 year. | Functional outcome as assessed by Constant Score, for a time of 1year.

cortical continuity.

时间窗: Radiological | features of union shall be looked for, such as, gradual disappearance of fracture line and | cortical continuity in 1 year. | Functional outcome as assessed by Constant Score, for a time of 1year.

features of union shall be looked for, such as, gradual disappearance of fracture line and

时间窗: Radiological | features of union shall be looked for, such as, gradual disappearance of fracture line and | cortical continuity in 1 year. | Functional outcome as assessed by Constant Score, for a time of 1year.

Functional outcome as assessed by Constant Score

时间窗: Radiological | features of union shall be looked for, such as, gradual disappearance of fracture line and | cortical continuity in 1 year. | Functional outcome as assessed by Constant Score, for a time of 1year.

次要结局

  • Complications such as non-union, malunion, hardware prominence, soft tissue irritation,(superficial skin infection, etc. shall be assessed along with the incidence of implant removal shall be assessed along with its cause.)

研究者

发起方
Pt BD Sharma PGIMS Rohtak
申办方类型
Government medical college

研究点 (1)

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