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临床试验/NCT05082844
NCT05082844撤回不适用

Evaluation of Mid- to Long-term Clinical and Radiological Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70

Istituto Ortopedico Rizzoli0 个研究点开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Constant score

研究概览

简要总结

The aim of the study is to document the clinical-radiological results from the case series of patients surgically treated for rotator cuff lesions from 2009 to 2020 at the Rizzoli Orthopaedic Institute Shoulder-Elbow Department.

详细描述

110 patients surgically treated for rotator cuff lesions from 2009 to 2020 will be included in a retrospective-prospective and interventional study with clinical and radiological evaluation at follow-up of at least 12 months.

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
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥70 years of age at the time of rotator cuff repair surgery
  • Males and Females
  • Patients surgically treated for rotator cuff injury between 2009 and 2020 at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute

排除标准

  • All available patients will be invited to undergo clinical examination and radiological examination. In case some patients cannot undergo MRI due to possible contraindications, they will still be seen to collect the primary clinical outcome

结局指标

主要结局

Constant score

时间窗: At least 12 months after cuff rotator lesion surgery

The constant score is the most commonly used questionnaire for evaluating treatment outcomes of shoulder disorders. It's the scoring system recommended by the European Society of Shoulder and Elbow Surgery (SECEC / ESSE). It has the advantages of including pain score, functional assessment, range of motion, and strength measures. A high score corresponds to a great quality of function

次要结局

  • Simple Shoulder Test (SST)(At least at leat 12 months after cuff rotator lesion surgery)
  • Magnetic Resonance Imaging(At least 12 months after cuff rotator lesion surgery)
  • Visual Analog Scale (VAS):(At least 12 months after cuff rotator lesion surgery)
  • Short Form-12 (SF-12):(At least 12 months after cuff rotator lesion surgery)
  • Treatment opinion post- surgery(At least 12 months after cuff rotator lesion surgery)

研究者

申办方类型
Other
责任方
Sponsor

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