Clinical Trials Directory

Trials / Completed

CompletedNCT01747759

Evaluation of a Preoperative Education in Total Knee Arthroplasty

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
44 (actual)
Sponsor
University Hospital, Clermont-Ferrand · Academic / Other
Sex
All
Age
55 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERKruskal-Wallis and qualitative parameters

Timeline

Start date
2010-11-01
Primary completion
2011-08-01
Completion
2012-03-01
First posted
2012-12-12
Last updated
2012-12-12

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01747759. Inclusion in this directory is not an endorsement.