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
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
Viswanathan V
Indira Ghandhi medical college and reasearch institute
