跳至主要内容
临床试验/NCT04686968
NCT04686968Unknown不适用

Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in the Treatment of Medium-sized Full-thickness Rotator Cuff Injuries: A Prospective Randomized Controlled Study

Beijing Jishuitan Hospital0 个研究点目标入组 48 人开始时间: 2021年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
48
主要终点
tendon integrity

研究概览

简要总结

Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.

详细描述

Arthroscopic rotator cuff repair has a high rate of successful subjective and functional results. Although the rate of tendon healing is reported to be around 80% for small tears, it can decrease to about 30% for large and massive tears. Poor tissue quality of bone, tendons, and muscles can affect healing and functional recovery of the rotator cuff and has been advocated as a major cause of tendon nonhealing and/or retear. Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.

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 (Participant)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Medium-sized full-thickness rotator cuff tear confirmed during shoulder arthroscopy
  • Between 20-65 years old

排除标准

  • Bilateral rotator cuff tear
  • Underwent ipsilateral surgery
  • Large-to-massive rotator cuff tear
  • Combined with Bankart, SLAP or AC lesion
  • Combined with diabetes, smoking, immune disease, osteoporosis, and large nodular cystic degeneration

结局指标

主要结局

tendon integrity

时间窗: 1 year postoperatively

MRI was used to assess the integrity of the repaired rotator cuff tendon

Visual Analogue Scale(VAS)

时间窗: 2 year postoperatively

A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome

American Shoulder and Elbow Surgeons Shoulder (ASES) score

时间窗: 2 years postoperatively

A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chunyan Jiang

Director of Sports Medicine Service of Beijing Jishuitan hospital

Beijing Jishuitan Hospital

相似试验

Microfracture Combined With Suture Bridge Technique... | 临床试验