Treatment of Unstable Distal Clavicular Fractures (Neer 2b): Hook Plate vs Locking Plate
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the postoperative complications
研究概览
简要总结
The investigators propose to test the hypotheses that compared with Hook Plate (HP), Locking Plate (LP) reduces the postoperative complications and leads to a better functional recovery after unstable distal clavicle fractures (Neer 2b).
详细描述
Controversy exists regarding the optimal treatment for patients with unstable distal clavicular fractures (Neer 2b). The recognized treatment alternatives are Hook plate.Notably, criticisms on this fixation method also appeared and the potential risks of hook migration, loosening, subacromial impingement or rotator cuff injury, and acromial osteolysis were still unsolved. Recently, Herrmann et al.and Largo et al.stabilized the distal clavicle with Locking plate (LP) and these studies offered encouraging support for LP. Because of small sample size (27 patients) and nonrandomization, the convictive power of these researches is not strong enough.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Unstable fractures of distal clavicle (Neer 2b fractures), acute or chronic and unilateral fractures.
- •Normal shoulder functions before injury.
- •Internal fixation with either HP or LP.
- •The subjects were in good health and were able to comply with all prescribed follow-up procedures.
排除标准
- •Patients who present multiple traumas.
- •Patients with other serious injuries to either upper limb that would interfere with rehabilitation.
- •Patients with a pathological, recurrent or open clavicle fracture.
- •Patient unwilling to give written informed consent.
- •Patients with cognitive impairment unable to comply with treatment programme.
- •Patients with a serious disorder of bone metabolism other than osteoporosis (e.g., endocrine bone diseases, osteomalacia and Paget's disease)
结局指标
主要结局
the postoperative complications
时间窗: 12 months
complication that related with surgery or fracture will be defined as any event that necessitated another operative procedure or additional medical treatment
次要结局
- the affected limb function(3, 6, 9,12 months)
研究者
Leisheng Jiang
director of department of Orthopaedic,Xinhua hospital
Shanghai Jiao Tong University School of Medicine