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Completed

NCT Number: NCT01747759

Evaluation of a Preoperative Education in Total Knee Arthroplasty

The benefit of preoperative rehabilitation treatment combining physiotherapy and targeted education for patient undergoing Total Knee replacement (TKR) is now well known. Thus, there is lack of validated booklet containing evidence based informations.

Our aim is to assess the impact of an evidence based education pre-operative booklet on patient's knowledge and beliefs. The secondary objectives are to assess the impact of the booklet on patient's satisfaction on the information received, the length of stay in orthopedic surgery and the transfer rate to rehabilitation wards.

To show a difference of 2 points on the knowledge score (range 0-10) between the two groups, with a = 0.05 and a power of 90%, we considered that 44 patients are needed. The evaluations will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher exact test.

The study protocol was approved by the local Ethic Committee.

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Key information

Conditions

Knee Osteoarthritis (Knee OA) Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

The benefit of preoperative rehabilitation treatment combining physiotherapy and targeted education for patient undergoing Total Knee replacement (TKR) is now well known. Thus, there is lack of validated booklet containing evidence based informations.

Our aim is to assess the impact of an evidence based education pre-operative booklet on patient's knowledge and beliefs. The secondary objectives are to assess the impact of the booklet on patient's satisfaction on the information received, the length of stay in orthopedic surgery and the transfer rate to rehabilitation wards.

To show a difference of 2 points on the knowledge score (range 0-10) between the two groups, with a = 0.05 and a power of 90%, we considered that 44 patients are needed. The evaluations will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher exact test.

The study protocol was approved by the local Ethic Committee.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ranging from 55 to 75 Planned total knee arthroplasty

Exclusion criteria

  • Age under 55 or above 75 Patients institutionalized Patients who have received a total knee arthroplasty of the ipsilateral knee Patient not affiliated to a social security scheme (beneficiary or assignee) Patients with chronic inflammatory rheumatism Cognitive and behavioral issues Disorders of understanding and expression of the French language TKR on complex knee

Treatment and study plan

Kruskal-Wallis and qualitative parameters

Other

Primary outcomes

  1. knowledge score

    Time frame: at day 1

Secondary outcomes

  1. pain

    Time frame: Baseline

  2. Primary disability

    Time frame: Baseline

  3. Duration of hospitalization surgery

    Time frame: at day 1

  4. Transfer rate in acute care and rehabilitation, and length of stay

    Time frame: at week 6

  5. Patient's overall satisfaction towards the information received

    Time frame: at week 6

  6. Patient's confidence in its own ability to achieve rehabilitation

    Time frame: at day-1

  7. Patient's knowledge and beliefs about his condition

    Time frame: Baseline, at day-1 and week 6

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Sanofi

Registry information

Acronym: EPOP

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Dec 12, 2012
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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