Early-term Effects of Microfracture on Tendon Vascularity and Healing in Arthroscopic Treatment of Chronic Rotator Cuff Tears: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- assessing early change of tendon and footprint area vascularity
研究概览
简要总结
Patients with complaints of shoulder pain or limitation of motion and had rotator cuff rupture diagnosed with magnetic resonance imaging will be analyzed and the patients with surgical indication will be included in a randomized fashion. One group of patient will undergo standard arthroscopic rotator cuff repair, while the other group will have microfracture procedure in addition to the standard arthroscopic repair. Before the operation, functional and clinical conditions will be recorded with Constant and American Shoulder and Elbow Surgeons Shoulder Score (ASES) universal shoulder scoring systems and Visual Analogue Scale(VAS) pain scale. The blood supply and healing of the tendon in the repair area will be compared by the doppler ultrasound (superb microvascular imaging) at the 2nd, 4th, 8th and 12th week after the operation. Post-operative clinical, functional status and pain levels will be evaluated with Constant, ASES and VAS pain scales at 24th week.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •degenerative rotator cuff tears
排除标准
- •traumatic rotator cuff tears
- •rheumatoid diseases
- •previous surgery of rotator cuff tendon
- •glenohumeral arthritis
- •acromioclavicular arthritis
结局指标
主要结局
assessing early change of tendon and footprint area vascularity
时间窗: 12th week
we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity
次要结局
- functional outcome(24th week)
研究者
Göker Utku değer
Research assistant
Istanbul University - Cerrahpasa (IUC)
