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临床试验/NCT02951403
NCT02951403Unknown不适用

Results of the Treatment of Patients With Elbow Osteoarthritis

Tampere University Hospital3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
3
主要终点
Quick DASH score

研究概览

简要总结

The study is a prospective case controlled clinical trial. The purpose of the study is to investigate the effect of elbow arthroscopy in the treatment for osteoarthritis of the elbow when compared to conservative treatment.

详细描述

Patients will be recruited at departments of hand surgery and orthopedic surgery outpatient clinics. The control group will be patients to whom the conservative treatment continues. Patients who meet the inclusion criteria will be asked to participate and sign the informed consent. Therefore the investigators have two treatment groups: group 1 who receives an elbow joint debridement arthroscopically without physiotherapy and group 2 who receives only conservative treatment with physiotherapy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Symptomatic post-traumatic or primary osteoarthritis - mechanical locking and/or decreased range of motion ( >30°)
  • •Radiographic evidence of at least mild primary or post-traumatic osteoarthritis according to Broberg - Morrey classification symptoms lasting at least 6 months
  • •Patients willingness to participate the study
  • •All patients 18-80 ages

排除标准

  • •Patients with previous severe soft tissue trauma at elbow region ( crush, burns etc - the elbow joint problems are not joint specific)
  • •Patients with crystal arthropathy or inflammatory arthritis
  • •Patient refuses to participate the study
  • •Patients with dementia or are institutionalized
  • •Patients with severe substance addiction
  • •Patient does not understand written and spoken guidance

研究组 & 干预措施

Operative treatment

Experimental

Patients to whom the elbow arthroscopy will be performed.

干预措施: Elbow arthroscopy (Procedure)

Conservative treatment

Other

Patients to whom special physiotherapy will be advised.

干预措施: Conservative treatment (Other)

结局指标

主要结局

Quick DASH score

时间窗: 24 Months

次要结局

  • Range of motion(24 Months)
  • VAS score(24 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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