NCT06726629

Crosscultural Adaptation And Validation Of The Italian Version Of The New Knee Society Knee Scoring System

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
OTHER	Version Of The New Knee Society Knee Scoring System	All patients will be subjected to the same clinical and radiographic checks, the data of which will be collected in the different centres

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-12-10
• Last updated: 2025-12-26

Locations

1 site across 1 country: Italy