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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01747759
First received: December 10, 2012
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Knee Osteoarthritis (Knee OA)
Other: Kruskal-Wallis and qualitative parameters

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • knowledge score [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pain [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
  • Primary disability [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
  • Duration of hospitalization surgery [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • Transfer rate in acute care and rehabilitation, and length of stay [ Time Frame: at week 6 ] [ Designated as safety issue: Yes ]
  • Patient's overall satisfaction towards the information received [ Time Frame: at week 6 ] [ Designated as safety issue: Yes ]
  • Patient's confidence in its own ability to achieve rehabilitation [ Time Frame: at day-1 ] [ Designated as safety issue: Yes ]
  • Patient's knowledge and beliefs about his condition [ Time Frame: Baseline, at day-1 and week 6 ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: November 2010
Study Completion Date: March 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747759

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Sanofi
Investigators
Principal Investigator: Stephane DESCAMPS University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01747759     History of Changes
Other Study ID Numbers: CHU-0133
Study First Received: December 10, 2012
Last Updated: December 11, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
• Knee osteoarthritis
Total knee arthroplasty
Selfcare
Booklet
Rehabilitation

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014