Crosscultural Adaptation And Validation Of The Italian Version Of The New Knee Society Knee Scoring System (KSS-ITALIAN)

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

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Version Of The New Knee Society Knee Scoring System

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: giulio maria marcheggiani muccioli, MD; Phone Number: 0516366356
• Study Contact Backup: Name: tosca cerasoli, MD

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • IRCCS Istituto Ortopedico Rizzoli
    • Contact: Giulio Maria Marcheggiani Muccioli, MD, PhD; Phone Number: +39 051 6366509; Email: marcheggianimuccioli@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The analysis will be performed on all patients undergoing primary Total Knee Replacement (TKA) surgery at one of the centers included in the study

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VALIDITY OF THE CONSTRUCT	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.	at baseline (Day 0); post-operative (day 3), at 1 year follow-up

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Collaborators: Ortopedia e Traumatologia - AO Ordine Mauriziano - Torino; Traumatologia dello Sport - Campus Bio-medico- Roma; Ortopedia e traumatologia - Policlinico di Modena; Ortopedia e Traumatologia-Istituto IFCA Firenze; Ortopedia e Traumatologia-Fondazione Poliambulanza Istituto Ospedaliero Brescia

Publications and helpful links

General Publications

• Goh GS, Liow MHL, Bin Abd Razak HR, Tay DK, Lo NN, Yeo SJ. Patient-Reported Outcomes, Quality of Life, and Satisfaction Rates in Young Patients Aged 50 Years or Younger After Total Knee Arthroplasty. J Arthroplasty. 2017 Feb;32(2):419-425. doi: 10.1016/j.arth.2016.07.043. Epub 2016 Aug 10.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: KSS
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: KSS-ITALIAN2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No