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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
University of Paris 5 - Rene Descartes
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01671917
First received: July 20, 2012
Last updated: June 27, 2016
Last verified: June 2016

July 20, 2012
June 27, 2016
October 2012
April 2018   (final data collection date for primary outcome measure)
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.
  • 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.
Complete list of historical versions of study NCT01671917 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty
Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Knee Osteoarthritis
  • 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
  • Other: Usual care
    Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.
  • Experimental: Educational and exercise program
    Intervention: Other: Educational and exercise program
  • Active Comparator: Usual care
    Intervention: Other: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
October 2018
April 2018   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years   (Adult, Senior)
No
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
 
NCT01671917
AOM 10042
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
  • Institut National de la Santé Et de la Recherche Médicale, France
  • University of Paris 5 - Rene Descartes
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
Assistance Publique - Hôpitaux de Paris
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP