Evaluation of a Preoperative Education in Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Knee Osteoarthritis (Knee OA)
• Interventions: Other: Kruskal-Wallis and qualitative parameters

• Registration Number: NCT01747759
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-08
• Study Completion: 2012-03
• Status Verified: 2012-12
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-11
• Last Update Submitted: 2012-12-11
• Study First Posted: 2012-12-12
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kruskal-Wallis and qualitative parameters	Kruskal-Wallis and qualitative parameters	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
Fisher exact test	Kruskal-Wallis and qualitative parameters	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

Primary Outcome Measures

Name	Time	Method
knowledge score	at day 1

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France