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Clinical Trials/NCT01747759
NCT01747759
Completed
Not Applicable

Evaluation of a Preoperative Education in Total Knee Arthroplasty

University Hospital, Clermont-Ferrand1 site in 1 country44 target enrollmentNovember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis (Knee OA)
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
44
Locations
1
Primary Endpoint
knowledge score
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
March 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

knowledge score

Time Frame: at day 1

Secondary Outcomes

  • Primary disability(Baseline)
  • Transfer rate in acute care and rehabilitation, and length of stay(at week 6)
  • pain(Baseline)
  • Duration of hospitalization surgery(at day 1)
  • Patient's overall satisfaction towards the information received(at week 6)
  • Patient's knowledge and beliefs about his condition(Baseline, at day-1 and week 6)
  • Patient's confidence in its own ability to achieve rehabilitation(at day-1)

Study Sites (1)

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