Evaluation of a Preoperative Education in Total Knee Arthroplasty
NCT ID: NCT01747759
Last Updated: 2012-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
44 participants
INTERVENTIONAL
2010-11-30
2012-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
Kruskal-Wallis and qualitative parameters
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Kruskal-Wallis and qualitative parameters
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
55 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephane DESCAMPS
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHU-0133
Identifier Type: -
Identifier Source: org_study_id