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

NCT06726629 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-12-26

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Ortopedia e Traumatologia - AO Ordine Mauriziano - Torino

    collaborator UNKNOWN

  • Traumatologia dello Sport - Campus Bio-medico- Roma

    collaborator UNKNOWN

  • Ortopedia e traumatologia - Policlinico di Modena

    collaborator UNKNOWN

  • Ortopedia e Traumatologia-Istituto IFCA Firenze

    collaborator UNKNOWN

  • Ortopedia e Traumatologia-Fondazione Poliambulanza Istituto Ospedaliero Brescia

    collaborator UNKNOWN

  • Istituto Ortopedico Rizzoli

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06726629 on ClinicalTrials.gov