Evaluation of a Preoperative Education in Total Knee Arthroplasty

Knee Osteoarthritis (Knee OA) Clinical Trial

— EPOP  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747759
• Other study ID #: CHU-0133
• Status: Completed
• Phase: N/A
• First received: December 10, 2012
• Last updated: December 11, 2012
• Start date: November 2010
• Est. completion date: March 2012

Study information

• Verified date: December 2012
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Knee Osteoarthritis (Knee OA)
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Kruskal-Wallis and qualitative parameters

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knowledge score		at day 1	Yes
Secondary	pain		Baseline	Yes
Secondary	Primary disability		Baseline	Yes
Secondary	Duration of hospitalization surgery		at day 1	Yes
Secondary	Transfer rate in acute care and rehabilitation, and length of stay		at week 6	Yes
Secondary	Patient's overall satisfaction towards the information received		at week 6	Yes
Secondary	Patient's confidence in its own ability to achieve rehabilitation		at day-1	Yes
Secondary	Patient's knowledge and beliefs about his condition		Baseline, at day-1 and week 6	Yes