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临床试验/NCT05184010
NCT05184010尚未招募不适用

Arthroscopic Treatment With and Without Ulnar Nerve Release for Elbow Osteoarthritis --a Prospective Randomized Controlled Trial

Beijing Jishuitan Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
1
主要终点
DASH

研究概览

简要总结

This study is a prospective randomized controlled study of arthroscopic release for primary osteoarthritis of the elbow with stiffness with or without ulnar nerve release. The patients with primary osteoarthritis of the elbow with stiffness, which ulnar neuropathy proven by electromyography without clinical symptoms, were randomly divided into groups before the operation. Before the arthroscopic operation was began, the procedure of ulnar nerve release was performed according to the group(release group or unrelease group). In different time periods postoperatively, the quantitative and qualitative indicators including pain, functional score, muscle strength, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with ulnar nerve release.

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
Double (Care Provider, Investigator)

入排标准

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

入选标准

  • Age >18 years
  • Primary osteoarthritis of the elbow with stiffness. Osteoarthritis was confirmed on CT-arthrography, by cartilage damage, osteophytes or local or global joint impingement.
  • Ulnar neuropathy proven by electromyography without clinical symptoms
  • Failure at least 6 months of conservative treatment
  • Availability of medical information for >2 years of follow-up

排除标准

  • Severe skin contracture or wound problem that could affect the neurovascular structures or require flap surgery.
  • Revision surgery
  • Ulnar nerve pathology results in clinical symptom such as motion and feeling deficiency
  • Other indication for elbow arthroscopy: synovial or inflammatory rheumatoid pathology, osteochondritis dissecan, acute infection, tumor or pure capsular stiffness.
  • Inadequate or loss of follow-up
  • elbow instability

结局指标

主要结局

DASH

时间窗: baseline-2 years postoperatively

A score used to evaluated the elbow function,range of 0-100, 100 means worst outcome

次要结局

  • Strength(baseline-2 years postoperatively)
  • MEPS(baseline-2 years postoperatively)
  • ROM(F-E and rotation)(baseline-2 years postoperatively)

研究者

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

Yi Lu

Director of Sports Medicine Service of Beijing Jishuitan hospital

Beijing Jishuitan Hospital

研究点 (1)

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