Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Knee Osteoarthritis |
Other: Educational and exercise program Other: Usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty |
- Ability to quit the orthopedic department [ Time Frame: at day 4 post surgery ] [ Designated as safety issue: No ]Ability to perform lying-sitting and sitting-standing transfers, walk 30 meters and go up and down one floor. It will be evaluated at day 4 (± 1 day) after the surgery.
- Change from baseline in functional recovery [ Time Frame: at 6 months ] [ Designated as safety issue: No ]Evaluated by the area under the curve of the WOMAC function index. It will be evaluated within the first 6 months.
- Pain [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]11-points numerical scale
- Function [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]WOMAC Index
- Quality of life [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]SF-36/EDQ5
- Number of steps [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Patient's reported
- Treatment satisfaction [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Ordinal scale
- Cost-effectiveness analysis of the two strategies of treatment. Cost-utility ratio [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Educational and exercise program |
Other: Educational and exercise program
|
| Active Comparator: Usual care |
Other: Usual care
Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.
|
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.
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
- 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
Contacts and Locations| Contact: Serge Poiraudeau, MD, PhD | + 33 1 58 41 25 49 | serge.poiraudeau@cch.aphp.fr |
| Contact: Laurence Lecomte, PhD | +33 1 71 19 64 94 | laurence.lecomte@nck.aphp.fr |
| France | |
| CHU Cochin | Recruiting |
| Paris, France, 75014 | |
| Contact: Katherine Sanchez, MD + 33 1 58 41 25 43 katherine.sanchez@cch.aphp.fr | |
| Principal Investigator: Serge Poiraudeau, MD, PhD | |
| Principal Investigator: | Serge Poiraudeau, MD, PhD | AP-HP, Descartes University, INSERM |
| Principal Investigator: | Pascal Richette, MD, PhD | CHU Lariboisière |
| Principal Investigator: | Emmanuel Coudeyre, MD, PhD | University Hospital, Clermont-Ferrand |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01671917 History of Changes |
| Other Study ID Numbers: | AOM 10042 |
| Study First Received: | July 20, 2012 |
| Last Updated: | January 1, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Total knee arthroplasty Total knee replacement Knee osteoarthritis Education Exercise |
Handicap Function Cost-effectiveness Cost-utility Quality of life |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013