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临床试验/NCT03526172
NCT03526172终止不适用

Assessing Physical Activity Levels of Patients Following High Tibial Osteotomy (HTO) With and Without Bone Grafting.

University of Winchester1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
1
主要终点
Objective physical activity levels (measured in steps per day)

研究概览

简要总结

High tibial osteotomy (HTO is often indicated in physically active patients. The insertion of a bone graft during surgery has been shown to have good clinical and biomechanical outcomes, however objective data regarding post-surgery physical activity (PA) levels in patients who have undergone HTO with and without bone grafts does not exist in the literature.

Using accelerometers and questionnaires, this study will be the first to investigate this in an objective way.

研究设计

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

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

  • Patient undergoing unilateral medial opening wedge high tibial osteotomy at Basingstoke & North Hampshire Hospital, UK

排除标准

  • Concurrent procedures during HTO surgery
  • The use of an off-loader knee brace in the 3 weeks leading up to surgery
  • Revision surgery

结局指标

主要结局

Objective physical activity levels (measured in steps per day)

时间窗: 14 weeks per patient

Physical activity data (step-count and body position) collected via an accelermeter that is attached to the thigh for 7 day periods at pre-determined intervals before and after surgery

Intensity of physical activity (measured in steps per minute)

时间窗: 14 weeks per patient

Physical activity data (step-count and body position) collected via an accelermeter that is attached to the thigh for 7 day periods at pre-determined intervals before and after surgery

次要结局

  • Subjective reasons, thoughts and feelings behind post-operative physical activity levels (thematic analysis)(1 hour per patient)
  • Subjective physical activity levels(14 weeks per patient)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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