Knee OsteoarthritisEDEXNCT01671917
Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty
A study testing Educational and exercise program in people with Knee Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Educational and exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2012to 29 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Educational and exercise program, Usual care
- Keywords
- Total knee arthroplasty, Total knee replacement, Knee osteoarthritis, Education, Exercise, Handicap, Function, Cost-effectiveness, Cost-utility, Quality of life
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational and exercise programOther
- 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
Usual careOther
Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.
| Study group | Role | What they receive |
|---|---|---|
| Educational and exercise program | Experimental | Not described Receives: Other: Educational and exercise program |
| Usual care | Active comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 months post-surgery
Secondary outcomes (13)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 12 months months post-surgery
Cost-effectiveness
Assessed by the cost-utility ratio
Measured: 6 months post-surgery
Cost-effectiveness
Assessed by the cost-utility ratio
Measured: 12 months months post-surgery
Adverse events
Assessed by self reporting using an open-ended question
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study start4 Oct 2012
- Primary completion22 Sep 2016
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Paris 5 - Rene Descartes, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- François Rannou, MD, PhD, Principal investigator, AP-HP, Descartes University, INSERMPascal Richette, MD, PhD, Principal investigator, CHU LariboisièreEmmanuel Coudeyre, MD, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671917
- Sponsor's protocol ID
- AOM 10042
- Acronym
- EDEX
- Status last verified
- Aug 2025
- First submitted
- 20 Jul 2012
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 35262716
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01671917
- Acronym / sponsor ID
- EDEX / AOM 10042
- Conditions
- Knee Osteoarthritis
- Keywords
- Total knee arthroplasty, Total knee replacement, Knee osteoarthritis, Education, Exercise, Handicap, Function, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Paris 5 - Rene Descartes, URC-CIC Paris Descartes Necker Cochin
- Study start
- 4 Oct 2012 (actual)
- Primary completion
- 22 Sep 2016 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 24 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational and exercise program | Experimental | Other: Educational and exercise program |
| Usual care | Active comparator | Other: Usual care |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Educational and exercise program |
| Usual careInformation and counseling usually provided in orthopedics department and an information booklet about knee replacement. | Other | Usual care |
Primary outcome
The percentage of patients able to quit independently the orthopedic department
Time frame: 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
Time frame: 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
13 secondary outcomes
Changes from baseline in mean knee pain in the previous 48 hrs
Time frame: 6 months post-surgery
Changes from baseline in mean knee pain in the previous 48 hrs
Time frame: 12 months post-surgery
Changes from baseline in mean function in the previous 48 hrs
Time frame: 6 months post-surgery
Changes from baseline in mean function in the previous 48 hrs
Time frame: 12 months post-surgery
Changes from baseline in mean quality of life
Time frame: 6 months post-surgery
Changes from baseline in mean quality of life
Time frame: 12 months post-surgery
Changes from baseline in the mean number of steps in the previous week
Time frame: 6 months post-surgery
Changes from baseline in the mean number of steps in the previous week
Time frame: 12 months post-surgery
Satisfaction with the treatment
Time frame: 6 months post-surgery
Satisfaction with the treatment
Time frame: 12 months months post-surgery
Cost-effectiveness
Time frame: 6 months post-surgery
Cost-effectiveness
Time frame: 12 months months post-surgery
Adverse events
Time frame: 12 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 35262716Nguyen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Rannou, MD, PhD principal investigator
AP-HP, Descartes University, INSERM
Pascal Richette, MD, PhD principal investigator
CHU Lariboisière
Emmanuel Coudeyre, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational and exercise program in people with Knee Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients able to quit independently the orthopedic department (time frame: at day 4 post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01671917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.