Actively Recruiting
Crosscultural Adaptation And Validation Of The Italian Version Of The New Knee Society Knee Scoring System
Led by Istituto Ortopedico Rizzoli · Updated on 2025-12-26
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
I
Istituto Ortopedico Rizzoli
Lead Sponsor
O
Ortopedia e Traumatologia - AO Ordine Mauriziano - Torino
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Crosscultural Adaptation And Validation Of The Italian Version Of The New Knee Society Knee Scoring System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Concomitant hip or spinal problems causing patient discomfort
- History of surgery on either knee
- Congenital knee deformities
- Previous septic arthritis
- Neuromuscular pathology such as polio
- Simultaneous bilateral prosthesis or prosthesis within 12 months of both knee, hip, and ankle
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
Research Team
G
giulio maria marcheggiani muccioli, MD
CONTACT
T
tosca cerasoli, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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