跳至主要内容
临床试验/NCT02287090
NCT02287090已完成不适用

Comparative Effectiveness of Operative Versus Non-Operative Treatments for Rotator Cuff Tears

Vanderbilt University Medical Center4 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
4
主要终点
Pain/Function (as measured by the SPADI outcome score)

研究概览

简要总结

Rotator cuff tears are one of the most common causes of shoulder pain. Evidence-based guidance on optimal diagnostic and treatment strategies for rotator cuff tears is lacking. Our proposed study aims to fill these gaps by identifying the prognostic factors which will predict better outcomes of rotator cuff tears, based on both operative and non-operative treatment. The investigators will also compare outcomes of operative and non-operative treatment of rotator cuff tears and report on the best way to diagnose rotator cuff tears.

详细描述

Rotator cuff tears account for over one quarter million surgeries annually. They are a leading cause of shoulder pain and disability. Patients with rotator cuff tears present with shoulder pain and/or limitation in range of motion. Fourteen special physical exam tests have been described for diagnosis of rotator cuff tears. Prior literature describing sensitivity and specificity of these tests in diagnosing cuff tears is limited by retrospective design, small sample sizes, samples restricted to patients undergoing surgery, and failure to differentiate between partial and full thickness tears. As a result, there is little evidence to help clinicians interpret the diagnostic value of the clinical exam. Consequently, clinicians rely heavily on magnetic resonance imaging (MRI) for diagnosing cuff tears, adding considerable expense in the diagnostic process.

The treatment options for rotator cuff tears are operative and non-operative. There is currently little consensus on indications and timing of rotator cuff surgery or non-operative treatment. Furthermore, there is lack of evidence-based guidance on factors associated with outcomes of operative versus non-operative treatment for cuff tears.

We are enrolling patients in a prospective cohort study to assess comparative-effectiveness of operative versus non-operative treatment of rotator cuff tears and understand prognostic factors for better outcomes after surgery and non-operative treatments.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 45 or older
  • Symptoms for at least 4 weeks of shoulder pain and/or limitation in range of motion of shoulder

排除标准

  • History of humeral fractures
  • Prior surgery on the same shoulder
  • Contraindications to MRI (prior surgical hardware, pacemakers, defibrillators, and claustrophobia)
  • Unable or unwilling to give informed consent
  • Unable or unwilling to be followed up
  • Non-English speaking (as questionnaires have only been validated in English)

结局指标

主要结局

Pain/Function (as measured by the SPADI outcome score)

时间窗: 24 months

Comparing patient pain/function \[as measured by the Shoulder Pain and Disability Index (SPADI) outcome instrument\] between patients undergoing surgery and patients choosing non-operative treatment.

次要结局

  • Pain/Function (as measured by the ASES outcome score)(24 months)
  • Pain/Function (as measured by the QuickDash outcome score)(24 months)
  • Effects of rotator cuff tear size on outcomes (as measured by the SPADI outcome instrument).(24 months)
  • Effects of patient age on outcomes (as measured by the SPADI outcome instrument).(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nitin Jain

Associate Professor of Physical Medicine and Rehabilitation and Orthopaedics

Vanderbilt University

研究点 (4)

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