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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Educational and exercise program; Other: Usual care

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 Type: Interventional
• Enrollment (Actual): 262
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • CHU Cochin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care	Other: Usual care; Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.
Experimental: Educational and exercise program	Other: Educational 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	6 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	12 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)	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)	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	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	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)	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)	12 months months post-surgery
Cost-effectiveness	Assessed by the cost-utility ratio	6 months post-surgery
Cost-effectiveness	Assessed by the cost-utility ratio	12 months months post-surgery
Adverse events	Assessed by self reporting using an open-ended question	12 months post-surgery

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; University of Paris 5 - Rene Descartes; Unité de Recherche Clinique Necker Cochin, France
• Investigators: Principal Investigator: François Rannou, MD, PhD, AP-HP, Descartes University, INSERM; Principal Investigator: Pascal Richette, MD, PhD, Chu Lariboisiere; Principal Investigator: Emmanuel Coudeyre, MD, PhD, University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• Nguyen C, Boutron I, Roren A, Anract P, Beaudreuil J, Biau D, Boisgard S, Daste C, Durand-Zaleski I, Eschalier B, Gil C, Lefevre-Colau MM, Nizard R, Perrodeau E, Rabetrano H, Richette P, Sanchez K, Zalc J, Coudeyre E, Rannou F. Effect of Prehabilitation Before Total Knee Replacement for Knee Osteoarthritis on Functional Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221462. doi: 10.1001/jamanetworkopen.2022.1462.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2012
• Primary Completion (Actual): September 22, 2016
• Study Completion (Actual): November 29, 2017

Study Registration Dates

• First Submitted: July 20, 2012
• First Submitted That Met QC Criteria: August 21, 2012
• First Posted (Estimated): August 24, 2012

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Quality of life; Total knee replacement; Knee osteoarthritis; Total knee arthroplasty; Cost-effectiveness; Function; Education; Cost-utility; Handicap
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Behavior; Osteoarthritis, Knee; Motor Activity
• Other Study ID Numbers: AOM 10042