Validation of the Italian version of the Knee Society Knee Scoring System
Crosscultural Adaptation And Validation Of The Italian Version Of The New Knee Society Knee Scoring System
This study is testing a new Italian version of a knee scoring system to see if it accurately measures knee function and pain in patients with knee osteoarthritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06726629 on ClinicalTrials.gov |
What this trial studies
This study focuses on adapting and validating the Italian version of the Knee Society Knee Scoring System (KSS) for patients with knee osteoarthritis. The process involves translating the original English questionnaire into Italian, ensuring cultural relevance through a series of translations and back-translations. The final version will be tested on 300 Italian patients who meet specific eligibility criteria, including those scheduled for primary total knee arthroplasty. The aim is to ensure that the Italian KSS accurately reflects the patients' knee function and pain levels.
Who should consider this trial
Good fit: Ideal candidates for this study are Italian-speaking patients aged 18 to 85 diagnosed with knee osteoarthritis and scheduled for primary total knee arthroplasty.
Not a fit: Patients with concurrent hip or spinal issues, previous knee surgeries, or congenital knee deformities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable tool for assessing knee function in Italian-speaking patients with osteoarthritis, leading to improved patient care.
How similar studies have performed: Other studies have successfully validated similar scoring systems in different languages, indicating a promising approach for this adaptation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: giulio maria marcheggiani muccioli, MD
- Phone: 0516366356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.