Ignite Creation Date:
2024-05-06 @ 1:10 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01747759
Status:
COMPLETED
Last Update Posted:
2012-12-12
First Post:
2012-12-10
Brief Title:
Evaluation of a Preoperative Education in Total Knee Arthroplasty
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPOP
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 patients knowledge and beliefs The secondary objectives are to assess the impact of the booklet on patients 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 005 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
Our aim is to assess the impact of an evidence based education pre-operative booklet on patients knowledge and beliefs The secondary objectives are to assess the impact of the booklet on patients 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 005 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 patients knowledge and beliefs The secondary objectives are to assess the impact of the booklet on patients 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 005 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
Our aim is to assess the impact of an evidence based education pre-operative booklet on patients knowledge and beliefs The secondary objectives are to assess the impact of the booklet on patients 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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None