search
Back to results

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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Educational and exercise program
Usual care
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Total knee arthroplasty, Total knee replacement, Knee osteoarthritis, Education, Exercise, Handicap, Function, Cost-effectiveness, Cost-utility, Quality of life

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Cochin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Educational and exercise program

Usual care

Arm Description

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)
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
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
Satisfaction with the treatment
Assessed by a self-administered 11-point numeric rating scale (0, not satisfied and 100, totally satisfied)
Satisfaction with the treatment
Assessed by a self-administered 11-point numeric rating scale (0, not satisfied and 100, totally satisfied)
Cost-effectiveness
Assessed by the cost-utility ratio
Cost-effectiveness
Assessed by the cost-utility ratio
Adverse events
Assessed by self reporting using an open-ended question

Full Information

First Posted
July 20, 2012
Last Updated
September 18, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, University of Paris 5 - Rene Descartes
search

1. Study Identification

Unique Protocol Identification Number
NCT01671917
Brief Title
Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty
Acronym
EDEX
Official Title
Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 4, 2012 (Actual)
Primary Completion Date
September 22, 2016 (Actual)
Study Completion Date
November 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, University of Paris 5 - Rene Descartes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Total knee arthroplasty, Total knee replacement, Knee osteoarthritis, Education, Exercise, Handicap, Function, Cost-effectiveness, Cost-utility, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational and exercise program
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Educational and exercise program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.
Primary Outcome Measure Information:
Title
The percentage of patients able to quit independently the orthopedic department
Description
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
Title
Changes from baseline in functional recovery
Description
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
Secondary Outcome Measure Information:
Title
Changes from baseline in mean knee pain in the previous 48 hrs
Description
Assessed by a self-administered 11-point numeric rating scale (0, no pain and 100, maximal pain)
Time Frame
6 months post-surgery
Title
Changes from baseline in mean knee pain in the previous 48 hrs
Description
Assessed by a self-administered 11-point numeric rating scale (0, no pain and 100, maximal pain)
Time Frame
12 months post-surgery
Title
Changes from baseline in mean function in the previous 48 hrs
Description
Assessed by the self-administered WOMAC function subscale (0, best function and 100, worse function)
Time Frame
6 months post-surgery
Title
Changes from baseline in mean function in the previous 48 hrs
Description
Assessed by the self-administered WOMAC function subscale (0, best function and 100, worse function)
Time Frame
12 months post-surgery
Title
Changes from baseline in mean quality of life
Description
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
Title
Changes from baseline in mean quality of life
Description
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
Title
Changes from baseline in the mean number of steps in the previous week
Description
Assessed by the self-reported number of steps monitored by a podometer
Time Frame
6 months post-surgery
Title
Changes from baseline in the mean number of steps in the previous week
Description
Assessed by the self-reported number of steps monitored by a podometer
Time Frame
12 months post-surgery
Title
Satisfaction with the treatment
Description
Assessed by a self-administered 11-point numeric rating scale (0, not satisfied and 100, totally satisfied)
Time Frame
6 months post-surgery
Title
Satisfaction with the treatment
Description
Assessed by a self-administered 11-point numeric rating scale (0, not satisfied and 100, totally satisfied)
Time Frame
12 months months post-surgery
Title
Cost-effectiveness
Description
Assessed by the cost-utility ratio
Time Frame
6 months post-surgery
Title
Cost-effectiveness
Description
Assessed by the cost-utility ratio
Time Frame
12 months months post-surgery
Title
Adverse events
Description
Assessed by self reporting using an open-ended question
Time Frame
12 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Rannou, MD, PhD
Organizational Affiliation
AP-HP, Descartes University, INSERM
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascal Richette, MD, PhD
Organizational Affiliation
CHU Lariboisière
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmanuel Coudeyre, MD, PhD
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Cochin
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35262716
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs