ISRCTN66352753已完成未知
All-arthroscopic versus mini-open repair of small or moderate sized rotator cuff tears: a randomised controlled trial using conventional and expertise-based designs
McMaster University (Canada)0 个研究点目标入组 250 人开始时间: 2008年6月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
2006 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/16529658 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34524031/ (added 08/06/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female patients
- •2. Aged 18 - 75 years
- •3. Small (0 - 1 cm) or moderate sized (1 - 3 cm) full-thickness rotator cuff tears of supraspinatus and infraspinatus, as determined by clinical examination and diagnostic imaging (magnetic resonance imaging [MRI]) prior to surgery
排除标准
- •Pre-operative exclusion criteria:
- •1. Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder or previous surgery of the affected shoulder
- •2. Evidence of significant cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations
- •3. Major medical illness (life expectancy less then two years or unacceptably high operative risk)
- •4. Unable to speak or read English
- •5. Psychiatric illness that precludes informed consent
- •6. Unwilling to be followed for two years
- •Intra-operative exclusion criteria:
- •7. Large, massive, or irreparable cuff tears, extending into the subscapularis or teres minor which cannot be mobilised to the articular margin or repaired with both techniques
- •8. Teres minor or subscapularis tears
- •9. Inelastic and immobile tendon, which cannot be advanced to articular margin
- •10. Co-existing labral pathologies requiring repair with sutures (superior labrum anterior posterior [SLAP] II - IV), Bankart lesions requiring repair, partial tears of biceps (more than 60% of thickness) requiring tenodesis or release
- •MRI exclusion criteria:
- •11. History of head or eye injury involving metal fragments
- •12. Ever worked in a metal shop or been a soldier
- •13. Presence of implanted electrical device (such as a cardiac pacemaker)
- •14. Severe heart disease (including susceptibility to arrhythmias)
- •15. Metal braces on teeth
- •16. Pregnancy
- •17. Presence of intrauterine device
研究者
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