Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel: A Multicenter, Randomized Controlled
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel
研究概览
简要总结
What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel.
It is the investigators' hypothesis that a peel of the subscapularis will result in greater strength, a higher healing rate, and a greater improvement in shoulder function and quality of life following shoulder replacement.
详细描述
The primary research question is to determine the difference in subscapularis strength between two different methods of subscapularis mobilization in shoulder arthroplasty: intra-substance division of the tendon "tenotomy" versus direct detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel". The primary outcome is strength as measured by a hand-held dynamometer in the belly-press position at one-year post operative. Secondary research questions include determination of the difference in disease specific quality of life between patients who undergo a subscapularis tenotomy versus subscapularis peel, as measured by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), Constant score and the ASES score at one year post-operatively. Finally, the healing rate of the subscapularis, as measured by ultrasound at 1 year post-operative will be determined.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Imaging, and intra-operative findings confirming advanced humeral head cartilage loss, and/glenoid cartilage loss.
- •Ability to understand and adhere to rehab protocols and testing procedure
- •Persistent pain and functional disability for at least 6 months and failure of 6 months of conservative treatment
- •surgical arthroplasty patients
排除标准
- •Active joint of systemic infection
- •Significant muscle paralysis
- •Rotator cuff tear arthropathy
- •Pregnancy
- •Charcot's arthropathy
- •Major medical illness ( life expectancy less then 1 year or unacceptably high operative risk)
- •Patients unable to provide informed consent due to language barrier or mental status
- •Unable to speak or read English/French
- •Psychiatric illness that precludes informed consent
- •Patients unwilling to be followed for the duration of the study.
结局指标
主要结局
What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel
时间窗: 12 months
What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel, as measured by a hand-held dynamometer in the belly-press position at one year post operative?
次要结局
- Quality of life as measured by WORC, ASES and Constant(12 months)