CompletedNot Applicable

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

France262 participantsStarted 2012-10-04

Plain-language 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.

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The percentage of patients able to quit independently the orthopedic department

Timeframe: at day 4 post-surgery

Changes from baseline in functional recovery

Timeframe: 6 months post-surgery

Trial details

NCT IDNCT01671917

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09-22

View on ClinicalTrials.gov More Knee Osteoarthritis trials

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.