Trials / Completed
CompletedNCT01747759
Evaluation of a Preoperative Education in Total Knee Arthroplasty
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- University Hospital, Clermont-Ferrand · Academic / Other
- Sex
- All
- Age
- 55 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Kruskal-Wallis and qualitative parameters |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2011-08-01
- Completion
- 2012-03-01
- First posted
- 2012-12-12
- Last updated
- 2012-12-12
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01747759. Inclusion in this directory is not an endorsement.