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

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ClinicalTrials.gov Identifier: NCT01671917
Recruitment Status : Recruiting
First Posted : August 24, 2012
Last Update Posted : June 28, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Knee Osteoarthritis 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty
Study Start Date : October 2012
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Active Comparator: Usual care Other: Usual care
Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.


Outcome Measures

Primary Outcome Measures :
  1. Ability to quit the orthopedic department [ Time Frame: at day 4 post surgery ]
    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.


Secondary Outcome Measures :
  1. Pain [ Time Frame: 6 and 12 months ]
    11-points numerical scale

  2. Function [ Time Frame: 6 and 12 months ]
    WOMAC Index

  3. Quality of life [ Time Frame: 6 and 12 months ]
    SF-36/EDQ5

  4. Number of steps [ Time Frame: 6 and 12 months ]
    Patient's reported

  5. Treatment satisfaction [ Time Frame: 6 and 12 months ]
    Ordinal scale

  6. Cost-effectiveness analysis of the two strategies of treatment. Cost-utility ratio [ Time Frame: 6 and 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671917


Contacts
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

Locations
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         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
University of Paris 5 - Rene Descartes
Investigators
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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01671917     History of Changes
Other Study ID Numbers: AOM 10042
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016

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