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临床试验/NCT03170128
NCT03170128已完成不适用

Functional Outcomes After Radial Head Fractures Treated Non-operatively

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2014年8月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Successful fracture union

研究概览

简要总结

The purpose of this study is to investigate the effects of physical therapy as part of the non-operative treatment of radial head fractures.There is currently no data to support the use of physical therapy in the non-operative treatment of radial head fractures. Likewise, there is no data that shows that physical therapy is harmful to patients being treated non-operatively for radial head fractures. Investigators believe that prescribing physical therapy for patients with non-displaced radial head fractures treated non-operatively is unnecessary, and that that it would be equally efficacious to teach patients simple stretching exercises that they could perform by themselves. Subjects will be randomized into 2 groups: Group 1 - Patients will be prescribed physical therapy within the first month following fracture; Group 2 - Patients will be given simple stretching exercises to perform at home and will not be given a prescription for physical therapy. Patients who agree to participate in this study and sign the informed consent will be randomly assigned to one of the two groups.

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
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals to be approached for participation in this study will include all adult (age > 18 years old) patients who are receiving or seeking medical care in the outpatient setting.

排除标准

  • Patients who are initially determined to need surgical fixation of a radial head fracture will not be included in this study. There are no additional exclusion criteria.

研究组 & 干预措施

Outpatient Physical Therapy

Active Comparator

干预措施: Outpatient physical therapy in addition to standard follow-up visits (Procedure)

Home Exercises

Active Comparator

干预措施: Home exercises in addition to standard follow-up visits (Behavioral)

结局指标

主要结局

Successful fracture union

时间窗: 3 Months

Demonstrated through x-rays

次要结局

  • Functional outcome score(3 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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