Single Row Versus Double Row Fixation in Arthroscopic Cuff Repair; a Randomized Controlled Sutdy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Western Ontario Rotator Cuff Index (WORC)
研究概览
简要总结
The study will identify if there is a difference of quality of life after surgery between two techniques used in surgery. The two different techniques are either the Single Row Fixation or the Double Row Fixation.
详细描述
Primary Research Question; What is the difference in disease specific quality of life between patients who undergo a repair of the rotator cuff with arthroscopic technique using single-row fixation, versus double-row fixation, as measured by the Western Ontario Rotator Cuff Index (WORC)at one year post op?
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff.
- •Imaging and intra-operative findings confirming a full thickness tear of the rotator cuff.
排除标准
- •Characteristics of the cuff tear that render the cuff irrepairable.
- •Significant shoulder comorbidities
- •Previous surgery on affected shoulder
- •Patients with active workers compensation claims
- •Active joint or systemic infection
- •Significant muscle paralysis
- •Rotatorcuff tear arthropathy
- •Charcots arthropathy
- •Major medical illness
- •Unable to speak or read English
- •Psychiatric illness that precludes informed consent
结局指标
主要结局
Western Ontario Rotator Cuff Index (WORC)
时间窗: 2 years
Do patients who undergo a repair of the rotator cuff with arthroscopic technique using double row fixation have increased disease specific quality of life (measured by WORC) then patients who undergo a repair with arthroscopic technique using single-row fixation? The WORC scale is from 0% to 100%, with a higher value being indicative of better disease specific quality of life.
次要结局
- Constant Score(2 Year)
- ASES Score(2 Year)
- Strength Test(2 Years)
- Healing Rate(1 Year)