To evaluate the outcome of management of displaced clavicular fractures using precontoured clavicular plates
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
- 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).
-
Road traffic accidents were observed to be the most common mode of injury.
-
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.
- 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.
- 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.
- 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.
- 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.)
