跳至主要内容
临床试验/NCT03039907
NCT03039907Unknown不适用

A Critical Assessment of the Factors That Promote or Limit the Return to Recreational, Work, and Physical Fitness Activities After Primary Total Knee Arthroplasty

Cincinnati Sportsmedicine Research and Education Foundation1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年1月23日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Analysis of Number of Participants That Return to Recreational and Fitness Activities

研究概览

简要总结

The main purpose of this study is to examine the factors that allow patients that undergo total knee arthroplasty to return to recreational sports and/or work activities, and to achieve recommended physical activity levels.

详细描述

There are three purposes of this study. The first purpose is to examine the factors that allow patients that underwent total knee arthroplasty with the Journey II to return to recreational sports and/or work activities, and to achieve recommended physical activity levels (defined by the American Heart Association and the American College of Sports Medicine).

The second purpose is to examine the factors that limit the ability of patients to resume sports, work, and physical fitness training, including comorbidities, general health, complications, and other factors.

The third purpose is to use advanced sports medicine rehabilitation principles that involve staged progressive protocols to safely prepare patients for sports, work, and physical fitness training. Objective measurements of muscle strength, endurance, balance, and neuromuscular control will be used to determine when patients may be cleared to participate in these activities.

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
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men or women 65 years of age or younger.
  • Patient indicates before surgery the desire to return to recreational (sports) and/or work activities postoperatively
  • Patient provides informed consent.
  • Patient complies with postoperative rehabilitation program.

排除标准

  • Patient did not desire to return to recreational and/or work activities after TKA
  • History of alcohol or drug abuse within 3 years of the operation.
  • Disabling or widespread osteoarthritis or other joint disease in any other joint.
  • Presence of a significant connective tissue disease, autoimmune disease, HIV-positive, or immune deficiency syndrome.
  • Any other contraindications that in the opinion of the principal investigator would interfere with the conduct of the study.

结局指标

主要结局

Analysis of Number of Participants That Return to Recreational and Fitness Activities

时间窗: 2 years postoperatively

Participants will complete a questionnaire that determines the type of physical activities they routinely participate in (for instance, swimming, bicycling, hiking, golf). Patients will also complete two questions regarding their general fitness level in accordance with current standards of the American Heart Association. These questions are contained in the study patient registry.

次要结局

  • Assessment of Effect of Preoperative Body Mass Index on Return to Recreational and Physical Activities(2 years postoperatively)
  • Assessment of Effect of Charlson Comorbidity Index on Return to Recreational and Physical Activities(2 years postoperatively)
  • Assessment of Postoperative Complications on Return to Recreational and Physical Activities(2 years postoperatively)

研究者

发起方
Cincinnati Sportsmedicine Research and Education Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sue Barber-Westin

Director Clinical Studies

Cincinnati Sportsmedicine Research and Education Foundation

研究点 (1)

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