Knee OsteoarthritisKSS-ITALIANNCT06726629
Crosscultural Adaptation And Validation Of The Italian Version Of The New Knee Society Knee Scoring System
An observational study of Knee Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Version Of The New Knee Society Knee Scoring System
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2024to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The analysis will be performed on all patients undergoing primary Total Knee Replacement (TKA) surgery at one of the centers included in the study
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
giulio maria marcheggiani muccioli, MD contact
tosca cerasoli, MD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Giulio Maria Marcheggiani Muccioli, MD, PhD, +39 051 6366509, marcheggianimuccioli@me.com
About this study
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:
- The English version of the KSS will be translated into Italian by 3 bilingual translators
- 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.
- 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
- Knee Osteoarthritis
- Being tested
- Version Of The New Knee Society Knee Scoring System
- Keywords
- KSS
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Version Of The New Knee Society Knee Scoring SystemOther
All patients will be subjected to the same clinical and radiographic checks, the data of which will be collected in the different centres
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: Version Of The New Knee Society Knee Scoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
VALIDITY OF THE CONSTRUCT
Comparison between the Italian version of the KSS and the tests already validated in Italian .In particular, the Pearson or Spearman coefficient (depending on the sample distribution) will be used to evaluate the correlation.
Measured: at baseline (Day 0); post-operative (day 3), at 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- Ortopedia e Traumatologia - AO Ordine Mauriziano - Torino, Campus Bio-Medico University, Ortopedia e traumatologia - Policlinico di Modena, Ortopedia e Traumatologia-Istituto IFCA Firenze, Ortopedia e Traumatologia-Fondazione Poliambulanza Istituto Ospedaliero Brescia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726629
- Sponsor's protocol ID
- KSS-ITALIAN2023
- Acronym
- KSS-ITALIAN
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 27593732
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crosscultural Adaptation And Validation Of The Italian Version Of The New Knee Society Knee Scoring System
- ClinicalTrials.gov ID
- NCT06726629
- Acronym / sponsor ID
- KSS-ITALIAN / KSS-ITALIAN2023
- Conditions
- Knee Osteoarthritis
- Keywords
- KSS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- Ortopedia e Traumatologia - AO Ordine Mauriziano - Torino, Campus Bio-Medico University, Ortopedia e traumatologia - Policlinico di Modena, Ortopedia e Traumatologia-Istituto IFCA Firenze, Ortopedia e Traumatologia-Fondazione Poliambulanza Istituto Ospedaliero Brescia
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The English version of the KSS will be translated into Italian by 3 bilingual translators
- 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.
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Version Of The New Knee Society Knee Scoring System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The analysis will be performed on all patients undergoing primary Total Knee Replacement (TKA) surgery at one of the centers included in the study
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Version Of The New Knee Society Knee Scoring SystemAll patients will be subjected to the same clinical and radiographic checks, the data of which will be collected in the different centres | Other | Patients |
Primary outcome
VALIDITY OF THE CONSTRUCT
Time frame: at baseline (Day 0); post-operative (day 3), at 1 year follow-up
Comparison between the Italian version of the KSS and the tests already validated in Italian .In particular, the Pearson or Spearman coefficient (depending on the sample distribution) will be used to evaluate the correlation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Results publication: PubMed 27593732Goh 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
giulio maria marcheggiani muccioli, MD contact
tosca cerasoli, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact giulio maria marcheggiani muccioli, MD (0516366356), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VALIDITY OF THE CONSTRUCT (time frame: at baseline (Day 0); post-operative (day 3), at 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06726629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.