Crosscultural Adaptation And Validation Of The Italian Version Of The New Knee Society Knee Scoring System
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 1 Nov 2024
- Expected to end
- Nov 2026
- Type of study
- Observational
- Treatments tested
- Version Of The New Knee Society Knee Scoring System
- Record updated
- 26 December 2025
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Concomitant hip or spinal problems, understood as a cause of patient discomfort even if not yet undergoing medical or rehabilitation therapy
- Previous septic arthritis
- History of ipsilateral or contralateral knee surgery
- Congenital knee deformities
- Neuromuscular pathology (e.g. polio)
- Simultaneous bilateral prosthesis or within 12 months of both knee, hip and ankle
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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:
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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
The group in the trial
- Patients
Treatment: Version Of The New Knee Society Knee Scoring System
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT06726629, who can take part
- Record updated
- 26 December 2025