Arthroscopic Assisted CC Stabilization Alone VS Additional K-wire Fixation for Acute Acromioclavicular Joint Injury, A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Acromioclavicular Joint Instability (ACJI) score
研究概览
简要总结
This RCT study is designed for comparing functional outcomes and radioligic outcomes between intervention group (Arthroscopic assisted CC-stabilzation with additional K-wire fixation) and control group (Arthroscopic assisted CC-stabilzation alone) for acute ACJI.
The main question it aims to answer is:
- Does Arthroscopic assisted CC-stabilization with additional K-wire fixation provide different outcomes in functional outcomes, CC-distance and GACA difference compare with arthroscopic assisted CC-stabilization alone in acute acromioclavicular joint injury?
详细描述
Acromioclavicular joint injury (ACJI) is one of the most common injury of shoulder joint. Most common mechanism of injury is from direct force apply to the affected shoulder, in adduction position, in acromion process area. Most of the intervention that have been used for treat ACJI are focused on pain control, maintain the strength of the joint, no limitation in daily life activity and full range of motion of affected shoulder. Operative treatment is indicated in ACJI Rockwood classification grade III, IV, V, and VI. Nowadays there are over 60 surgical techniques without gold standard. Arthroscopic assisted CC-stabilzation is one of the most popular technique that has been used for ACJI.
This RCT study is designed for comparing functional outcomes (ACJI score, VAS, Constant score and DASH score) and radioligic outcomes (CC-distance difference, GACA difference) between intervention group (Arthroscopic assisted CC-stabilzation with additional K-wire fixation) and control group (Arthroscopic assisted CC-stabilzation alone) for acute ACJI.
The main question it aims to answer is:
- Does Arthroscopic assisted CC-stabilization with additional K-wire fixation provide different outcomes in functional outcomes, CC-distance and GACA difference compare with arthroscopic assisted CC-stabilization alone in acute acromioclavicular joint injury?
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-45 years old
- •Acute AC joint injury rockwood classification III, IV and V
排除标准
- •History of underwent previous ipsilateral shoulder surgery
- •Specific active associated ipsilateral injury (Rib fractures, clavicel fractures, scapula fractures and base of coracoid fractures)
- •Onset of injury more than 3 weeks
- •Cannot underwent arthroscopic assisted CC-stabilization surgery
结局指标
主要结局
Acromioclavicular Joint Instability (ACJI) score
时间窗: 1 year post-operative
Functional outcome, Rated from 0-100, higher score means better function of the shoulder
次要结局
- Gleno-acromio-clavicular angle (GACA) difference(3months postop, 6 months postop, 1 year postop)
- Constant score(3months postop, 6 months postop, 1 year postop)
- VAS(3months postop, 6 months postop, 1 year postop)
- Coracoclavicular (CC) distance diference(Postoperative day 1, 2weeks postop, 6weeks postop, 3months postop, 6 months postop, 1 year postop)
- DASH score(3months postop, 6 months postop, 1 year postop)