Does Additional Horizontal Fixation After Arthroscopically Assisted Coracoclavicular Stabilisation Matter in Final Outcome Measures: a Prospective Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Constant-Murley score, minimum score 1, maximum score 100 (higher = better)
研究概览
简要总结
Comparing different treatement strategies in augmenting clavicle stabilisation
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •consensus indication for surgical treatment of AC syndesmolysis
- •OP in 3 weeks after injury
- •patient age between 16 and 65 years
- •normal shoulder function before injury
排除标准
- •open injury
- •ipsilateral arm/shoulder girdle/hand injuries
- •very low patient's physical demands
- •previous injuries of the affected area
- •Rockwood classification 1, 2, or 6
研究组 & 干预措施
group with tape augmentation of acromioclavicular (AC) joint
patients randomised in this group will have additional tape fixation around AC joint. Both groups will however have fixation in CC area.
干预措施: non-absorbable tape fixation around AC joint (Procedure)
group with tape augmentation of acromioclavicular (AC) joint
patients randomised in this group will have additional tape fixation around AC joint. Both groups will however have fixation in CC area.
干预措施: coracoclavicular (CC) fixation (Procedure)
group without tape augmentation of AC joint
patients randomised in this group will not have additional tape fixation around AC joint. Both groups will however have fixation in CC area.
干预措施: no fixation around AC joint (Procedure)
group without tape augmentation of AC joint
patients randomised in this group will not have additional tape fixation around AC joint. Both groups will however have fixation in CC area.
干预措施: coracoclavicular (CC) fixation (Procedure)
结局指标
主要结局
Constant-Murley score, minimum score 1, maximum score 100 (higher = better)
时间窗: 1 year
patient-reported outcome measure (PROM)
次要结局
- Horizontal RTG measurements, measured in mm(1 year)
- Horizontal RTG measurements, measured in mm2(1 year)
- SACS - specific AC score, minimum score 1, maximum score 100 (higher = better)(1 year)
研究者
Miha Ambrožič
Principal Investigator
University Medical Centre Ljubljana