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临床试验/NCT04454060
NCT04454060已完成不适用

Study on the Development of Arthroscopic Treatment of Refractory Tennis Elbow

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2018年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

The aim of this study was to investigate the exploration history, key theories, methods, and techniques involved in the evolution from the intracapsular method to the extracapsular method for arthroscopic treatment of tennis elbow, and explore the effectiveness and safety of extracapsular method on the basis of retrospective analysis of 43 cases.

详细描述

Background: Arthroscopic surgery is widely used in the treatment of refractory tennis elbow due to its advantages of minimally invasive, safe and direct vision. Intra-capsular arthroscopy(intracapsular method), which is performed via natural cavity, is the mainstream arthroscopic procedure. However, intracapsular method requires the damage of joint capsule and may cause intraoperative neurovascular injury and other complications. In view of the defects of intracapsular method, the surgical scheme of the extracapsular arthroscopy (referred to as "extracapsular method") has emerged. The aim of this study was to investigate the exploration history, key theories, methods, and techniques involved in the evolution from the intracapsular method to the extracapsular method for arthroscopic treatment of tennis elbow, and explore the effectiveness and safety of extracapsular method.

Methods: Qualitative data were collected via focus group interview. 7 surgeons who were selected through purposive sampling discussed on the theories, methods, and technical specifications of the transition from intracapsular method to extracapsular method. Qualitative data were analysed using NVivo11. Quantitative data of consecutive 43 patients were analysed to evaluate the effectiveness and safety of the extracapsular method. Descriptive analysis was conducted to analyse the demographic characteristics and clinical outcomes after surgery.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosis was refractory tennis elbow;
  • Standard extracapsular method was used for surgery.

排除标准

  • Patient had past history of joint infection, joint tuberculosis, or osteomyelitis, or the upper limb had undergone surgery within the past 6 months;
  • Diagnosis was combined with severe heart, brain, kidney, or another organ dysfunction;
  • Case was complicated with other serious elbow joint diseases or injuries;
  • Patient did not sign the informed consent form.

结局指标

主要结局

Visual Analog Scale

时间窗: 12 months

Use Visual Analog Scale(VAS) to evaluate the pain recovery of patients who received extracapsular arthroscopic treatment. VAS ranges from 0 to 10, higher scores mean a worse outcome.

Mayo Elbow Performance Score

时间窗: 12 months

Use Mayo Elbow Performance Score(MEPS) to evaluate the functional recovery of patients who received extracapsular arthroscopic treatment. MEPS ranges from 0 to 100, higher scores mean a better outcome.

Disability of Arm, Shoulder and Hand score

时间窗: 12 months

Use Disability of Arm, Shoulder and Hand(DASH) score to evaluate the functional and pain recovery of patients who received extracapsular arthroscopic treatment. DASH ranges from 0 to 100, higher scores mean a worse outcome.

Activity of Daily Life recovery time

时间窗: 12 months

Use Activity of Daily Life recovery time to evaluate the functional recovery of patients who received extracapsular arthroscopic treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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