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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: Usual care; Other: Educational and exercise program

• Registration Number: NCT01671917
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-24
• Study Start: 2012-10-04
• Primary Completion: 2016-09-22
• Study Completion: 2017-11-29
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	-
Educational and exercise program	Educational and exercise program	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes from baseline in mean knee pain in the previous 48 hrs	12 months post-surgery	Assessed by a self-administered 11-point numeric rating scale (0, no pain and 100, maximal pain)
Changes from baseline in mean function in the previous 48 hrs	12 months post-surgery	Assessed by the self-administered WOMAC function subscale (0, best function and 100, worse function)
Changes from baseline in the mean number of steps in the previous week	12 months post-surgery	Assessed by the self-reported number of steps monitored by a podometer
Satisfaction with the treatment	12 months 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 quality of life	12 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)
Cost-effectiveness	12 months months post-surgery	Assessed by the cost-utility ratio
Adverse events	12 months post-surgery	Assessed by self reporting using an open-ended question

Trial Locations

Locations (1)

CHU Cochin; 🇫🇷 Paris, France