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临床试验/NCT01671917
NCT01671917已完成不适用

Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2012年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
262
试验地点
2
主要终点
The percentage of patients able to quit independently the orthopedic department

研究概览

简要总结

The purpose of this study is to determine whether a standardized education and exercise program proposed before a total knee replacement for knee osteoarthritis is effective in functional recovery after surgery.

详细描述

Knee osteoarthritis leads to deficiencies in muscle strength, knee range of motion and balance, and cardio respiratory deconditioning that contribute to alter abilities to perform activities of daily living. It is the principal indication for total knee arthroplasty (TKA). Patients' functional state and pain level are generally improved after TKA and the physical and functional status pre-TKA are predictive of recovery after surgery. Decreasing length of stay at surgery departments and promoting return at home after TKA are recommended. The recommendations of the Health Authority in France (HAS) and the new law of finance for French clinics contribute to shorter hospital stays and to restrain the conditions of admission to Physical Medicine and Rehabilitation department after TKA.Exercise and education programs conducted before TKA could help better prepare patients for surgery, improve functional outcome and accelerate functional recovery after surgery thus reducing the length of stay in orthopedic departments and facilitate return to home (directly or after a stay in PMR departments). The type of program necessary to achieve those goals remains to be defined.A systematic review of the literature associated with an analysis of practices about the relevance of rehabilitation programs before TKA, concluded that the implementation of such programs before TKA was likely to reduce the length of stay in surgery departments and improve the rate of direct return to home after surgery but that high quality trials were lacking. It also suggested that association of exercise programs with educational ones could be more effective than exercise or education alone, particularly for fragile patients with impaired functional capacity, co-morbidities and/or social problems.

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
Single (Participant)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female aged 50 to 85 years
  • Patient suffering from knee osteoarthritis according to ACR for which a total knee arthroplasty is scheduled
  • Preliminary medical examination whose results will be transmitted to the patient
  • Patient giving his informed consent to participate in the study
  • Patient affiliated to or beneficiary of social insurance

排除标准

  • Patients institutionalized
  • Patients who have already received an ipsilateral total knee arthroplasty
  • Patients with chronic inflammatory arthritis
  • Cognitive or behavioral disorders making assessment impossible
  • Inability to speak and write French
  • TKA indicated for other reason than osteoarthritis

结局指标

主要结局

The percentage of patients able to quit independently the orthopedic department

时间窗: at day 4 post-surgery

Assessed by the ability to perform lying-sitting and sitting-standing transfers, walk 30 meters and go up and down one floor at day 4 (± 1 day) after the surgery. Each item will be scored on a 4-class scale (0, unable to perform and 3, able to perform independently). Ability to quite the orthopedic department will be defined as scoring 3 out of 3 for all 4 assessed items on the day of discharge from the orthopedic department.

Changes from baseline in functional recovery

时间窗: 6 months post-surgery

Assessed by the area under the curve of the function subscale of the WOMAC index within the first 6 months post-surgery

次要结局

  • Changes from baseline in mean knee pain in the previous 48 hrs(12 months post-surgery)
  • Changes from baseline in mean function in the previous 48 hrs(12 months post-surgery)
  • Changes from baseline in the mean number of steps in the previous week(12 months post-surgery)
  • Satisfaction with the treatment(12 months months post-surgery)
  • Changes from baseline in mean quality of life(12 months post-surgery)
  • Cost-effectiveness(12 months months post-surgery)
  • Adverse events(12 months post-surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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