Case Series to Evaluate Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Complication
研究概览
简要总结
There are many surgical methods available for the treatment of patients with acromioclavicular dislocations. No single method has yet proven to be superior to the others.
The purpose of this study is to evaluate the clinical outcome and complications associated with coracoclavicular ligament repair using autogenous gracilis tendon graft implanted in a single transclavicle transcoracoid bone tunnel. The implantation is performed using an endobutton system that augments the repair with fibrewires.
The investigators will prospecitvely follow 30 patients enrolled in the study.
The hypthesis is that this near anatomical repair of the coracoclavicular ligaments will result in good clinical outcome and few complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years old.
- •Shoulder trauma within last 2 weeks.
- •Pain from the acromioclavicular joint.
排除标准
- •Chronic or concomitant acromioclavicular joint pathology on injured side.
- •Previous acromioclavicular joint dislocation on contralateral side.
- •Major shoulder pathology on affected side.
- •Mental inability to take part in rehabilitation.
- •Non Swedish or English speaking patients.
研究组 & 干预措施
Surgery
Surgical repair of acromioclavicular dislocation.
干预措施: Surgical treatment of acromioclavicular dislocation. (Procedure)
结局指标
主要结局
Complication
时间窗: 12 months after surgery.
* Redislocations. * Other local complications, eg. infection.
Disabilities of the Arm, Shoulder and Hand Score
时间窗: 12 months after surgery.
次要结局
- Constant-Murley Score(12 months after surgery)
研究者
Jonas Nordin
Medical Intern
Helsingborgs Hospital