IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136, Italy
Location status: Recruiting
NCT Number: NCT06726629
The present study aims to be a multicenter prospective analysis aimed at validating the Italian version of the new KSS introduced in 2011 15. To do this it is first necessary to create the translation of the questionnaire. Several steps will be performed to obtain an adequate Italian version of the new KSS:
1. The English version of the KSS will be translated into Italian by 3 bilingual translators 2. The 2 versions will be submitted to the study collaborators (one per centre), the final version (accepted by all the study collaborators) will be translated back into English by 2 bilingual translators (native English) not aware of the initial version. The back translation will then be sent to the original author (Prof. Scott) to ensure that the consistency of the questionnaire has been maintained throughout all processes despite the necessary cultural adaptations. 3. Once the definitive version has been obtained, it will be tested by 300 Italian patients (with an estimated dropout of 20%) suffering from gonarthrosis. The patients will be distributed as follows: approximately 50 patients in each of the 6 centers (total 300). The number of patients was chosen considering approximately 17-18 patients for each of the 17 items, this choice is consistent with previously published studies on translation into other languages
Interested in participating?
Request Info18 year–85 year
All sexes
Observational
Bologna, 40136, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients will be subjected to the same clinical and radiographic checks, the data of which will be collected in the different centres
Time frame: at baseline (Day 0); post-operative (day 3), at 1 year follow-up
Comparison between the Italian version of the KSS and the tests already validated in Italian .In particular, the Pearson or Spearman coefficient (depending on the sample distribution) will be used to evaluate the correlation.
Contact information is provided by the study sponsor or research team.
Istituto Ortopedico Rizzoli
Other
Acronym: KSS-ITALIAN
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