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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
262
* 4 (twice a week) group education sessions lasting 30 minutes plus an education booklet about knee replacement * 4 (twice a week) sessions of an exercise programme lasting 1 hour
Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.
CHU Cochin
Paris, France
The percentage of patients able to quit independently the orthopedic department
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.
Time frame: at day 4 post-surgery
Changes from baseline in functional recovery
Assessed by the area under the curve of the function subscale of the WOMAC index within the first 6 months post-surgery
Time frame: 6 months post-surgery
Changes from baseline in mean knee pain in the previous 48 hrs
Assessed by a self-administered 11-point numeric rating scale (0, no pain and 100, maximal pain)
Time frame: 6 months post-surgery
Changes from baseline in mean knee pain in the previous 48 hrs
Assessed by a self-administered 11-point numeric rating scale (0, no pain and 100, maximal pain)
Time frame: 12 months post-surgery
Changes from baseline in mean function in the previous 48 hrs
Assessed by the self-administered WOMAC function subscale (0, best function and 100, worse function)
Time frame: 6 months post-surgery
Changes from baseline in mean function in the previous 48 hrs
Assessed by the self-administered WOMAC function subscale (0, best function and 100, worse function)
Time frame: 12 months post-surgery
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Changes from baseline in mean quality of life
Assessed by the physical and mental components of the self-administered SF-12 questionnaire (0, worse quality of life and 100, best quality of life) and by the self-administered EQ-5D-3L questionnaire (11111, best quality of life and 33333, worse quality of life)
Time frame: 6 months post-surgery
Changes from baseline in mean quality of life
Assessed by the physical and mental components of the self-administered SF-12 questionnaire (0, worse quality of life and 100, best quality of life) and by the self-administered EQ-5D-3L questionnaire (11111, best quality of life and 33333, worse quality of life)
Time frame: 12 months post-surgery
Changes from baseline in the mean number of steps in the previous week
Assessed by the self-reported number of steps monitored by a podometer
Time frame: 6 months post-surgery
Changes from baseline in the mean number of steps in the previous week
Assessed by the self-reported number of steps monitored by a podometer
Time frame: 12 months post-surgery
Satisfaction with the treatment
Assessed by a self-administered 11-point numeric rating scale (0, not satisfied and 100, totally satisfied)
Time frame: 6 months post-surgery
Satisfaction with the treatment
Assessed by a self-administered 11-point numeric rating scale (0, not satisfied and 100, totally satisfied)
Time frame: 12 months months post-surgery
Cost-effectiveness
Assessed by the cost-utility ratio
Time frame: 6 months post-surgery
Cost-effectiveness
Assessed by the cost-utility ratio
Time frame: 12 months months post-surgery
Adverse events
Assessed by self reporting using an open-ended question
Time frame: 12 months post-surgery