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Evaluation of a Preoperative Education in Total Knee Arthroplasty (EPOP)

Primary Purpose

Knee Osteoarthritis (Knee OA)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Kruskal-Wallis and qualitative parameters
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Knee Osteoarthritis (Knee OA) focused on measuring • Knee osteoarthritis, Total knee arthroplasty, Selfcare, Booklet, Rehabilitation

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Kruskal-Wallis and qualitative parameters

Fisher exact test

Arm Description

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 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

Outcomes

Primary Outcome Measures

knowledge score

Secondary Outcome Measures

pain
Primary disability
Duration of hospitalization surgery
Transfer rate in acute care and rehabilitation, and length of stay
Patient's overall satisfaction towards the information received
Patient's confidence in its own ability to achieve rehabilitation
Patient's knowledge and beliefs about his condition

Full Information

First Posted
December 10, 2012
Last Updated
December 11, 2012
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01747759
Brief Title
Evaluation of a Preoperative Education in Total Knee Arthroplasty
Acronym
EPOP
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis (Knee OA)
Keywords
• Knee osteoarthritis, Total knee arthroplasty, Selfcare, Booklet, Rehabilitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kruskal-Wallis and qualitative parameters
Arm Type
Other
Arm Description
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
Arm Title
Fisher exact test
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Kruskal-Wallis and qualitative parameters
Primary Outcome Measure Information:
Title
knowledge score
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
pain
Time Frame
Baseline
Title
Primary disability
Time Frame
Baseline
Title
Duration of hospitalization surgery
Time Frame
at day 1
Title
Transfer rate in acute care and rehabilitation, and length of stay
Time Frame
at week 6
Title
Patient's overall satisfaction towards the information received
Time Frame
at week 6
Title
Patient's confidence in its own ability to achieve rehabilitation
Time Frame
at day-1
Title
Patient's knowledge and beliefs about his condition
Time Frame
Baseline, at day-1 and week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane DESCAMPS
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28678854
Citation
Eschalier B, Descamps S, Pereira B, Vaillant-Roussel H, Girard G, Boisgard S, Coudeyre E. Randomized blinded trial of standardized written patient information before total knee arthroplasty. PLoS One. 2017 Jul 5;12(7):e0178358. doi: 10.1371/journal.pone.0178358. eCollection 2017.
Results Reference
derived

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Evaluation of a Preoperative Education in Total Knee Arthroplasty

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