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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Other: Educational and exercise program; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT01671917

AOM 10042

Details and patient eligibility

About

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.

Full 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.

Enrollment: 262 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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262 participants in 2 patient groups

Educational and exercise program

Experimental group

Treatment:

Other: Educational and exercise program

Usual care

Active Comparator group

Treatment:

Other: Usual care