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临床试验/NCT03609164
NCT03609164已完成不适用

Does the Arthroscopic Suture-spanning Augmentation of Single-row Repair in Massive Rotator Cuff Tear Reduce the Retear Rate?

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Retear rate

研究概览

简要总结

There are several associated structural changes when dealing with massive rotator cuff repair, which include tendon retraction and fragility, muscle atrophy and fatty infiltration, as well as osteoporosis over the tendon insertion. Those changes may lead to difficult in applying double-row repair, suture cutting through the tendon, too much tension over the repair and loosening or pull-out of anchors, which may results in poor tendon-bone healing and subsequent high re-tear rate. Therefore decreasing the tension over the repair site may increase the healing over tendon bone junction as well as decrease the risk of anchors loosening. A suture-spanning augmentation with two set of suture loops passing over musculotendinous junction medially and fixed with anchor at the lateral cortical wall may solve the problem. In order to define the clinical benefit of this adjuvant procedure, a prospective randomized control study is designed to compare the adjunctive reinforce suture with the single-row simple suture repair in massive rotator cuff tear.

Around sixty patients were randomized divided into two groups. The study group was used adjunctive reinforce suture repair technique, which was one lateral cortical anchor holding 2 separated set of transverse looping sutures over the medial musculotendinous junction in addition to single row repair, while the control group was used single row repair technique in simple stitch fashion. All patients will have clinical evaluation in pain (VAS score) and functional recovery (ASES and UCLA score) as well as MRI image for the tendon integrity.

If the suture-spanning augmentation of single-row repair can yield an improved healing rate and fewer complications, massive rotator cuff tear should be repaired earlier in order to prevent the late development of irreparable tear.

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, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the pre-operative image (MRI) showing the massive rotator cuff tear (fulfilling one of the following definition a tear with a diameter of 5 cm or more; a complete tear of two or more tendons; one with a coronal length and sagittal width greater than or equal to 2 cm)
  • patient was willing and able to provide scores for the study

排除标准

  • irreparable rotator cuff tear which was identified pre-operatively or intra-operatively
  • glenohumeral or acromioclavicular joint osteoarthritis
  • stage III or more of the fatty degenerative of supraspinatus in Goutallier classification
  • revision surgery
  • patients with bacteremia, a systemic infection, or an infection at the surgical site
  • patients who previously attempted or failed a treatment program

研究组 & 干预措施

Suture-spanning augmentation of single-row repair

Experimental

干预措施: Suture-bridge augmentation of single-row repair (Procedure)

single-row repair

Active Comparator

干预措施: Suture-bridge augmentation of single-row repair (Procedure)

结局指标

主要结局

Retear rate

时间窗: 6 months

Using MR imaging to determine the presence or absence of rotator cuff retears

次要结局

  • The American Shoulder and Elbow Surgeons (ASES) Shoulder Score(2 years)
  • University of California at Los Angeles Shoulder Score (UCLA Shoulder Score)(2 years)
  • Shoulder constant score(2 years)
  • Visual Analog Score (VAS)(2 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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