Crosscultural Adaptation And Validation Of The Italian Version Of The New Knee Society Knee Scoring System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Version Of The New Knee Society Knee Scoring System.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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
Primary outcome measures
- VALIDITY OF THE CONSTRUCT [Time frame: at baseline (Day 0); post-operative (day 3), at 1 year follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Istituto Ortopedico Rizzoli — Bologna
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. PMID 27593732
Identifiers
NCT: NCT06726629 · KSS-ITALIAN2023