Acromio-clavicular Joint Dislocation Type III. Conservative Treatment Compared to Surgical Management With 3.5mm Clavicle Hook Plate. A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Functional results of injured shoulder on Constant score
研究概览
简要总结
Acromio-clavicular (AC) joint dislocation corresponds to 8.6% of all joint dislocations and represents a major injury to the shoulder girdle. The nature of the treatment is decided according to the severity of the lesion.
The purpose of this study is to determine whether the surgical treatment is required or not for type III AC joint dislocations.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men or women ≥ 18 years-old;
- •AC joint dislocation type III with Zanca X-ray view demonstrating CC distance of 200%;
- •trauma-surgery delay of less than 14 days;
- •consent form signed.
排除标准
- •AC joint dislocation type I, II, IV, V or VI;
- •associated neuro-vascular damage;
- •men or women > 60 years-old;
- •open dislocation;
- •local skin damage;
- •dislocation in a polytrauma patient;
- •floating shoulder;
- •fracture of the ipsilateral or controlateral arm or shoulder girdle;
- •fracture of the coracoid process of the scapula;
- •history of previous surgery to the shoulder;
- •medical condition preventing surgery;
- •men or women unfit to consent;
- •any other condition that make the examinator thinks that the follow up would be problematic.
结局指标
主要结局
Functional results of injured shoulder on Constant score
时间窗: 3 months after surgery
Based on the patient's subjective and objective answers to the Constant and Murley questionnaire, data are collected and calculated over a 100 points to measure the functional score of the injured shoulder. Also, to measure shoulder strength, the Isoforce system from MDS® is used.
次要结局
- Return to professional activities(3 months after surgery)
- Rate of secondary surgery(up to 12 months after surgery)
- Social impact on SF-36 scale(12 months after surgery)
- Functional difference(6 months after surgery)
- Radiologic assessment on the Zanca and axillary views(6 weeks after surgery)
- Rate of complications(up to 12 months after surgery)
- Pain on Visual analog scale (VAS)(6 weeks after surgery)
- Pain on VAS(12 months after surgery)
研究者
Pelet Stephane
Dr Stephane Pelet MD, PhD Orthopedic surgeon
Hopital de l'Enfant-Jesus