Knee Osteoarthritis
Conditions
Keywords
Total knee arthroplasty, Total knee replacement, Knee osteoarthritis, Education, Exercise, Handicap, Function, Cost-effectiveness, Cost-utility, Quality of life
Brief summary
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.
Detailed description
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.
Interventions
OTHEREducational and exercise program
* 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
OTHERUsual care
Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
University of Paris 5 - Rene Descartes
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of patients able to quit independently the orthopedic department | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in mean quality of life | 6 months post-surgery | 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) |
| Changes from baseline in the mean number of steps in the previous week | 6 months post-surgery | Assessed by the self-reported number of steps monitored by a podometer |
| Changes from baseline in mean knee pain in the previous 48 hrs | 6 months post-surgery | Assessed by a self-administered 11-point numeric rating scale (0, no pain and 100, maximal pain) |
| Cost-effectiveness | 6 months post-surgery | Assessed by the cost-utility ratio |
| Adverse events | 12 months post-surgery | Assessed by self reporting using an open-ended question |
| Satisfaction with the treatment | 6 months post-surgery | Assessed by a self-administered 11-point numeric rating scale (0, not satisfied and 100, totally satisfied) |
| Changes from baseline in mean function in the previous 48 hrs | 6 months post-surgery | Assessed by the self-administered WOMAC function subscale (0, best function and 100, worse function) |
Countries
France
Outcome results
None listed