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

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 Overview

• Status: Completed
• Conditions: Knee Osteoarthritis (Knee OA)
• Intervention / Treatment: Other: Kruskal-Wallis and qualitative parameters

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Other: Kruskal-Wallis and qualitative parameters
Other: 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	Other: Kruskal-Wallis and qualitative parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
knowledge score	at day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Sanofi
• Investigators: Principal Investigator: Stephane DESCAMPS, University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Estimate): December 12, 2012
• Last Update Submitted That Met QC Criteria: December 11, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Rehabilitation; Total knee arthroplasty; Booklet; • Knee osteoarthritis; Selfcare
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CHU-0133