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

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ClinicalTrials.gov Identifier: NCT01747759
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : December 12, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Knee Osteoarthritis (Knee OA) 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : November 2010
Primary Completion Date : August 2011
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. knowledge score [ Time Frame: at day 1 ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01747759     History of Changes
Other Study ID Numbers: CHU-0133
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

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