跳至主要内容
临床试验/NCT04421417
NCT04421417暂停不适用

Early-term Effects of Microfracture on Tendon Vascularity and Healing in Arthroscopic Treatment of Chronic Rotator Cuff Tears: A Prospective Randomized Trial

Göker Utku değer2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年9月15日最近更新:
适应症

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

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

发起方
Göker Utku değer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Göker Utku değer

Research assistant

Istanbul University - Cerrahpasa (IUC)

研究点 (2)

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