Arthroscopic Coracoclavicular Ligament Reconstruction Using Knot Hiding Titanium Implants: a Prospective Randomized Two-year Follow up Study Comparing Two Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Total number of wound infections in the clavicular describing the safety of the used implant
研究概览
简要总结
This study follows early wound healing using knot hiding titanium implants in coracoclavicular ligament reconstruction. A further aim is to compare two techniques where the semitendinosus tendon graft either runs through the coracoid drill hole or goes around the coracoid.
详细描述
A modified arthroscopic technique for coracoclavicular ligament reconstruction was used based on a previous technique where the supportive device and the semi tendon graft share the clavicular and coracoid drill holes. A notable problem with the previous technique was large protruding suture knots on the washer and clavicle, which could predispose to wound infection. In this new modified technique, new implants were introduced. The new implant hides the suture knot and less foreign material is needed.
The purpose of this study is to follow the patients operated using the new implants with special attention to early clavicular wound healing. A further aim is to compare a technique where the semitendinosus graft runs through clavicular and coracoid drill holes versus a technique where the graft runs under the coracoid process.
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 (Investigator)
盲法说明
Either the two operation methods is chosen by opening a sealed envelope.
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of chronic acromioclavicular luxation
排除标准
- •Severe new trauma after the treatment
结局指标
主要结局
Total number of wound infections in the clavicular describing the safety of the used implant
时间窗: two months
Clinical sign questionnaire, scale 0-1 (no-yes)
次要结局
- Clavicular tunnel diameter(The measure is taken postoperatively and after two years follow-up)
- Coracoclavicular distance(The measure is taken postoperatively and after two years follow-up)
- Simple shoulder test, scale 0-12, 12 denoting excellent(Score is taken postoperatively and after two years follow-up)
- Nottingham clavicle score, scale 20-100, 100 denoting excellent(Score is taken postoperatively and after two years follow-up)
- Constant score, scale 0-100, 100 denoting excellent(Score is taken postoperatively and after two years follow-up)
研究者
Dr Juha Ranne
Principal investigator
University of Turku