Clinical trial NCT01671917: Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty
Official title: Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total knee arthroplasty
Total knee replacement
Knee osteoarthritis
Education
Exercise
Handicap
Function
Cost-effectiveness
Cost-utility
Quality of life
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: University of Paris 5 - Rene Descartes
First posted: 2012-08-24
Enrollment: 262
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The percentage of patients able to quit independently the orthopedic department
timeFrame: at day 4 post-surgery
measure: Changes from baseline in functional recovery
timeFrame: 6 months post-surgery
Secondary outcomes:
measure: Changes from baseline in mean knee pain in the previous 48 hrs
timeFrame: 6 months post-surgery
measure: Changes from baseline in mean knee pain in the previous 48 hrs
timeFrame: 12 months post-surgery
measure: Changes from baseline in mean function in the previous 48 hrs
timeFrame: 6 months post-surgery
measure: Changes from baseline in mean function in the previous 48 hrs
timeFrame: 12 months post-surgery
measure: Changes from baseline in mean quality of life
timeFrame: 6 months post-surgery
measure: Changes from baseline in mean quality of life
timeFrame: 12 months post-surgery
measure: Changes from baseline in the mean number of steps in the previous week
timeFrame: 6 months post-surgery
measure: Changes from baseline in the mean number of steps in the previous week
timeFrame: 12 months post-surgery
measure: Satisfaction with the treatment
timeFrame: 6 months post-surgery
measure: Satisfaction with the treatment
timeFrame: 12 months months post-surgery
measure: Cost-effectiveness
timeFrame: 6 months post-surgery
measure: Cost-effectiveness
timeFrame: 12 months months post-surgery
measure: Adverse events
timeFrame: 12 months post-surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: CHU Cochin
Study officials:
affiliation: AP-HP, Descartes University, INSERM
name: François Rannou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Lariboisière
name: Pascal Richette, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Clermont-Ferrand
name: Emmanuel Coudeyre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.