Crosscultural Adaptation And Validation Of The Italian Version Of The New Knee Society Knee Scoring System
Recruiting
Observational Study
Knee Osteoarthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Istituto Ortopedico Rizzoli · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 translato…
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
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 sp…
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
Contacts
giulio maria marcheggiani muccioli, MD
0516366356
CONTACT
tosca cerasoli, MD
CONTACT
What are you hoping to find?
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.