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临床试验/NCT01481480
NCT01481480Unknown不适用

A Multicenter, Randomized Controlled Trial Comparing Functional Outcomes After Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears

Unity Health Toronto1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Constant-Murley score

研究概览

简要总结

A massive tear of the rotator cuff is a debilitating condition that causes pain, significant impairments in strength, and resultant loss of activity of the affected arm. To our knowledge, there is no Level 1 evidence comparing surgical procedures to treat massive rotator cuff tears. Adding the first randomized controlled trial to will be a substantial contribution to the current body of evidence available in the subject of massive rotator cuff tears. Most studies found in the literature following patients with massive rotator cuff tears are retrospective, have small numbers of patients, offer no control group and do not adequately compare treatment methods.Moreover, there is no consensus from experts regarding which treatment is superior.

Our multicentre orthopaedic study group proposes a multicentre randomized clinical trial prospectively comparing latissimus dorsi tendon transfer to arthroscopic management for the treatment of massive rotator cuff tears. This study will include the use of comprehensive functional, motor and radiographic outcome assessments.

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 (Outcomes Assessor)

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

  • Men or women aged 40 to 65 years of age
  • Massive rotator cuff tear, identified by MRI as being greater than 4cm in greatest diameter.
  • Provision of informed consent

排除标准

  • Absence of functioning latissimus dorsi muscle (assessed by "cough test"
  • Absence of subscapularis muscle insertion (assessed by MRI)
  • Glenohumeral arthritis of Grade 2 or higher, including evidence of acromio-humeral arthritis
  • Acute tears (identifiable injury which precluded symptoms in past 6 months)
  • Neurologic injury causing paralysis of affected shoulder girdle/arm
  • Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery (ASA Grade IV or higher)
  • Anticipated problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

结局指标

主要结局

Constant-Murley score

时间窗: 2 years

Constant-Murley score at 2 years

次要结局

  • Quick Dash(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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