Ultrasonic Tenotomy as a Treatment of Partial Rotator Cuff Tear of the Supraspinatus Tendon: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in pain
研究概览
简要总结
The focus of this study is to examine changes in pain scores, strength, and range of motion over time following an ultrasonic tenotomy on a partial tear (<50%) of the supraspinatus tendon of the rotator cuff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Evidence of partial tear (< 50%) of the supraspinatus tendon on MRI.
排除标准
- •A tear of the supraspinatus tendon greater > 50% and any areas of full thickness tearing, concomitant tears > 25% of other rotator cuff tendons (infraspinatus, teres minor or subscapularis), or acute tear of the glenoid labrum.
- •Evidence of systemic illness/infection requiring oral or IV antibiotics during the recruitment period.
- •Evidence of overlying skin infection or lesion at the proposed device insertion point on the shoulder.
- •Previous corticosteroid injection within three months.
- •Those individuals less than 25 and greater than 75 years of age will be excluded.
研究组 & 干预措施
Repair a partially torn rotator cuff
Subjects will undergo an ultrasonic tenotomy to repair a partially torn rotator cuff per standard of care as clinically indicated
干预措施: Ultrasonic tenotomy (Procedure)
结局指标
主要结局
Change in pain
时间窗: Baseline, 2, 6, 12 and 24-weeks post-procedure
Measured using a visual analog scale (VAS), used to measure subjective pain, rated from 0 (no pain) to 100 (most severe pain) at rest and during activity (previously painful activities)
Change in shoulder active range of motion
时间窗: Baseline, 2, 6, 12 and 24-weeks post-procedure
Measured using a goniometer reported in degrees
Change in shoulder strength
时间窗: Baseline, 2, 6, 12 and 24-weeks post-procedure
Assessed using a hand-held dynamometer (HHD) placed distally on the forearm, just proximal to the wrist joint along the distal radius and ulna with instruction to push into the HHD with maximum force production for approximately 5 seconds.
次要结局
- Change in quality of life(Baseline, 2, 6, 12 and 24-weeks post-procedure)
研究者
Jacob L. Erickson
Principal Investigator
Mayo Clinic