Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 19
- 主要终点
- Shoulder Pain & Disability Index (SPADI)
研究概览
简要总结
Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.
详细描述
This is non-blinded, randomized controlled trial. Patients will be randomly assigned to either an operative or non-operative course of treatment and will be followed for 12 months from baseline.
Aim 1: To compare pain and function in patients undergoing operative versus non-operative treatment of atraumatic rotator cuff tears at 12 months of follow-up
Aim 2: To assess effects of rotator cuff tear size and age on comparative outcomes of operative versus non-operative treatments for atraumatic rotator cuff tears
5U34AR069201-02 NIH grant funded the preparatory work for the trial but not the trial itself.
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
- None
入排标准
- 年龄范围
- 40 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged =>40 years to <85 years
- •Shoulder pain and/or loss of range of active motion, strength or function
- •MRI-confirmed partial- or full-thickness supraspinatus and/or infraspinatus tear of 4cm or less in longitudinal dimension
- •Medically fit for surgery, defined as Category I-III per American Society of Anesthesiologists (ASA) Physical Status Classification
- •Ability and willingness to provide informed consent
排除标准
- •Primary diagnosis is something other than a rotator cuff tear
- •History (in last 2 years) of shoulder fracture involving the humeral head on affected side
- •Previous rotator cuff surgery on affected side
- •Isolated subscapularis &/or teres minor tear on affected side
- •Acute rotator cuff tear caused by a severe trauma
- •Shoulder used as a weight-bearing joint
- •Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.)
- •Glenohumeral osteoarthritis on xrays/MRI, as determined by recruiting MD
- •Grade 4 fatty infiltration of rotator cuff (any tendons)
- •Candidate for shoulder arthroplasty at baseline
- •Non-English speaking
研究组 & 干预措施
Operative
surgery + post-operative physical therapy
干预措施: Arthroscopic Rotator Cuff Surgery (Procedure)
Operative
surgery + post-operative physical therapy
干预措施: Physical Therapy (Procedure)
Non-Operative
non-operative physical therapy
干预措施: Physical Therapy (Procedure)
结局指标
主要结局
Shoulder Pain & Disability Index (SPADI)
时间窗: Study participants will be followed for 12 months
SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst.
次要结局
- American Shoulder and Elbow Surgeons (ASES)(Study participants will be followed for 12 months)
研究者
Nitin Jain
Professor of Physical Medicine & Rehabilitation, and Orthopaedics
University of Michigan