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Clinical Trials in Italy / NCT06726629
Recruiting Observational

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

NCT06726629 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Ortopedico Rizzoli
Phase
Observational
Started
2024-11-01
Last updated
2025-12-26

Condition(s) studied

Knee Osteoarthritis

Investigational drug(s) / intervention(s)

Version Of The New Knee Society Knee Scoring System

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

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IRCCS Istituto Ortopedico Rizzoli Bologna Italy Recruiting

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Other trials for the same condition

Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis Active, not recruiting
Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis Recruiting
Comparison of Custom and Standard Total Knee Replacements Recruiting
Clinical and Radiological Results of Long Term Tibial and Femoral Osteotomy in Knee Ostheoarthritis With Concomitant Lower Limb Malalignement Recruiting
Homologus PRP in the Infiltrative Treatment of Knee Osteoarthritis in Young Athletic Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06726629 on ClinicalTrials.gov ↗ ← All trials in Italy