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临床试验/CTRI/2024/11/076612
CTRI/2024/11/076612已完成3 期

STUDY OF FUNCTIONAL OUTCOME OF OPERATIVE -TITANIUM ELASTIC NAILING SYSTEM (TENS) VERSUS NON-OPERATIVE FIGURE OF 8 BANDAGE TREATMENT FOR ALLMAN GROUP I DISPLACED MIDDLE ONE-THIRD CLAVICLE FRACTURE – A RANDOMIZED CONTROL STUDY SYSTEM (TENS) VERSUS NON-OPERATIVE FIGURE OF 8 BANDAGE TREATMENT FOR ALLMAN GROUP I DISPLACED MIDDLE ONE-THIRD CLAVICLE FRACTURE- A RANDOMIZED CONTROL STUDY

Department of Orthopaedics1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月21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
60
试验地点
1
主要终点
Operative TENS treatment is better than conservative figure of 8 bandage treatment

研究概览

简要总结

Clavicle is the only vertical long bone that connects thorax and shoulder griddle and helps in free movement around the shoulder joint . 4-12% of all the fractures of the body contributed by clavicle and among that 80% is only by mid shaft clavicle fracture . Traditionally, most of the mid clavicle fractures are managed conservatively by using figure of 8 bandage and arm sling. It has a advantage of being non-invasive and there is no exposure to anaesthesia. Conservative management has a risk of non-union, residual deformity and higher patient dissatisfaction as it need regular adjustment and regular fallow up but still most of the mid clavicle fractures managed conservatively without any serious consequences . Recent study shows there is a increasing trend of surgical management for mid clavicle fractures due to higher malunion rate 15 % and patients dissatisfaction rate of 31 % . Most commonly used surgical methods for management of mid clavicle fracture are plating and intramedullary nailing with TENS. Both these methods showed superior functional results compared to non-conservative treatment. Compared to plating TENS has a benefit of minimally invasive with good cosmetic result and aim at exact restoration of length and early return to activity

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Simple closed displaced middle one third clavicle fractures • Comminuted fracture mid-shaft clavicle.

排除标准

  • • Compound fractures of clavicle • Pathological fractures • Patient with hemiparesis on the affected side • Associated rib fracture in the affected side • Associated pneumothorax • Bilateral clavicle fracture • Associated scapular fracture • Known immuno-deficiencies • Old malunions and non-unions of clavicle • Associated with neurovascular injury • Patients with head injury.

结局指标

主要结局

Operative TENS treatment is better than conservative figure of 8 bandage treatment

时间窗: Outcome assessed in 2 weeks, 6 weeks, 3months and 6 months

次要结局

  • Figure of 8 bandage treatment is better than conservative operative TENS treatment(Outcome assessed in 2 weeks, 6 weeks,3 months and 6 months)

研究者

发起方
Department of Orthopaedics
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Viswanathan V

Indira Ghandhi medical college and reasearch institute

研究点 (1)

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