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NCT Number: NCT06726629

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

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Giulio Maria Marcheggiani Muccioli, MD, PhD

CONTACT

[email protected]

+39 051 6366509

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of gonarthrosis and indication for primary TKA surgery
  • Age between 18 and 85 years
  • Ability to respond to the proposed questionnaires and provide informed consent
  • Availability for follow-up for one year after surgery

Exclusion criteria

  • Concomitant hip or spinal problems, understood as a cause of patient discomfort even if not yet undergoing medical or rehabilitation therapy
  • History of ipsilateral or contralateral knee surgery
  • Congenital knee deformities
  • Previous septic arthritis
  • Neuromuscular pathology (e.g. polio)
  • Simultaneous bilateral prosthesis or within 12 months of both knee, hip and ankle

Treatment and study plan

Version Of The New Knee Society Knee Scoring System

Other

All patients will be subjected to the same clinical and radiographic checks, the data of which will be collected in the different centres

Primary outcomes

  1. VALIDITY OF THE CONSTRUCT

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

giulio maria marcheggiani muccioli, MD

CONTACT

0516366356

tosca cerasoli, MD

CONTACT

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

  • Campus Bio-Medico University
  • Ortopedia e Traumatologia - AO Ordine Mauriziano - Torino
  • Ortopedia e Traumatologia-Fondazione Poliambulanza Istituto Ospedaliero Brescia
  • Ortopedia e Traumatologia-Istituto IFCA Firenze
  • Ortopedia e traumatologia - Policlinico di Modena

Registry information

Acronym: KSS-ITALIAN

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2024
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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