Crosscultural Adaptation And Validation Of The Italian Version Of The New Knee Society Knee Scoring System
NCT ID: NCT06726629
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-11-01
2026-11-30
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Ortopedia e Traumatologia - AO Ordine Mauriziano - Torino
UNKNOWN
Traumatologia dello Sport - Campus Bio-medico- Roma
UNKNOWN
Ortopedia e traumatologia - Policlinico di Modena
UNKNOWN
Ortopedia e Traumatologia-Istituto IFCA Firenze
UNKNOWN
Ortopedia e Traumatologia-Fondazione Poliambulanza Istituto Ospedaliero Brescia
UNKNOWN
Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Locations
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IRCCS Istituto Ortopedico Rizzoli
Bologna, , Italy
Countries
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Central Contacts
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giulio maria marcheggiani muccioli, MD
Role: CONTACT
Phone: 0516366356
tosca cerasoli, MD
Role: CONTACT
Facility Contacts
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Giulio Maria Marcheggiani Muccioli, MD, PhD
Role: primary
References
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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.
Other Identifiers
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KSS-ITALIAN2023
Identifier Type: -
Identifier Source: org_study_id