Clinical Trial to Compare the Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Grade III Dislocations
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
The aim of this study is to compare two therapeutical procedures for the grade III acromioclavicular dislocations, either open reduction and internal fixation with a coracoclavicular device (MINAR-STORZ ) or non operative treatment.
For these purpose we have designed an interventional, prospective, parallel assignment, opened and randomized study.
详细描述
Acromioclavicular dislocations are one of the most frequent traumatic lesions of the scapular girdle. They represent the 40-50% of the sport related shoulder injuries.
There are different grades of dislocations being classified by Altman- Rockwood in 6 types. There is consensus for non operative treatment in types 1 and 2 and for surgical treatment in types 4, 5 and 6.
For type 3 both therapeutic techniques are accepted with no high scientific evidence studies supporting either of them.
During de 70's, surgical treatment was recommended for all these lesions but in the early 90´s surgeons´s preferences changed into the non-operative treatment. Now a day, treatment is decided according to the surgeon experience and the functional demands of the patient.
The aim of this study is to compare the results of non-operative treatment and open reduction and internal fixation with a coracoclavicular reconstruction device (MINAR-STORZ) in grade III acromioclavicular 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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years.
- •Grade III acromioclavicular dislocation.
- •Signed informed consent.
排除标准
- •Any condition that may impair the functional recovery or the patient collaboration with the rehabilitation program (cognitive disability, neurological pathology, tumoral disease...).
- •Previous acromioclavicular osteoarthritis.
- •Previous acromioclavicular lesions.
- •Concomitant lesions in the ipsilateral limb or in the contralateral shoulder.
- •Polytraumatized patients.
- •Any disease or condition the investigator finds decisive for exclusion.
研究组 & 干预措施
open reduction internal fixation
open reduction internal fixation
干预措施: open reduction internal fixation (Procedure)
non operative treatment
'sling rest and early functional recovery
干预措施: sling rest and early functional recovery (Other)
结局指标
主要结局
Efficacy
时间窗: 12 months
Efficacy will be measured for the AMERICAN SHOULDER AND ELBOW SURGEONS EVALUATION (ASES) and the CONSTANT score.
次要结局
- X-ray evaluation(12 months)
研究者
Carlos Alvarez
MD
Hospital General Universitario Gregorio Marañon