Scale Reliability ValidityVACKPNCT07386405
Validation and Cultural Adaptation of the KOOS-ACL Scale for the Italian Population
An observational study of Scale Reliability Validity and ACL Injury, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Submission of the KOOS ACL questionnaires in Italian for the purpose of validation and cultural adaptation of the KOOS-ACL scale for the Italian population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scale Reliability Validity, ACL Injury, Validation and Cultural Adaptation of a Scale
- What is being tested?
- PROMS submition
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jan 2026to 1 Jul 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of anterior cruciate ligament injury, undergoing or being considered for ACL reconstruction surgery.
Who may be able to join
- Patient age 18 years or older
- Patients who are native Italian speakers
- Patients undergoing anterior cruciate ligament reconstruction of the knee
- Patients who have understood and signed the informed consent to participate in the study.
- Patients who are able to understand the study conditions and participate for the entire duration
Who cannot join
- Patients unable to understand the text in Italian
- Patients undergoing knee replacement surgery, corrective osteotomies, or osteosynthesis of knee fractures.
- Patients who are drug addicts, alcoholics, suffer from psychiatric disorders, or have any clinical conditions that could compromise the success of the questionnaire.
- Patients with orthopedic conditions of other origins
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Italian Version of KOOS-ACL (Knee Injury and Osteoarthritis Outcomes Score - Anterior Cruciate Ligament): Translation, Cross-cultural Adaptation and Validation
Submission of the KOOS ACL questionnaires in Italian for the purpose of validation and cultural adaptation of the KOOS-ACL scale for the Italian population.
- Conditions
- Scale Reliability Validity, ACL Injury, Validation and Cultural Adaptation of a Scale, PROMs
- Being tested
- PROMS submition
- Keywords
- scale reliability, ACL, KOOS-ACL, PROMs
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMS submitionOther
KOOS ACL submission to validate and transalte the scale for italian people
What is being measured
The primary outcome is the main question the study is designed to answer.
validated translation and cultural adaptation of the KOOS-ACL scale in Italian.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start19 Jan 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scale Reliability ValidityStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386405
- Sponsor's protocol ID
- KOOS-ACL Validation (VACKP)
- Acronym
- VACKP
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Version of KOOS-ACL (Knee Injury and Osteoarthritis Outcomes Score - Anterior Cruciate Ligament): Translation, Cross-cultural Adaptation and Validation
- ClinicalTrials.gov ID
- NCT07386405
- Acronym / sponsor ID
- VACKP / KOOS-ACL Validation (VACKP)
- Conditions
- Scale Reliability Validity, ACL Injury, Validation and Cultural Adaptation of a Scale, PROMs
- Keywords
- scale reliability, ACL, KOOS-ACL, PROMs
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 19 Jan 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 4 Feb 2026 (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.
Submission of the KOOS ACL questionnaires in Italian for the purpose of validation and cultural adaptation of the KOOS-ACL scale for the Italian population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of anterior cruciate ligament injury, undergoing or being considered for ACL reconstruction surgery.
Key inclusion criteria (5 listed)
- Patient age 18 years or older
- Patients who are native Italian speakers
- Patients undergoing anterior cruciate ligament reconstruction of the knee
- Patients who have understood and signed the informed consent to participate in the study.
- Patients who are able to understand the study conditions and participate for the entire duration
Key exclusion criteria (4 listed)
- Patients unable to understand the text in Italian
- Patients undergoing knee replacement surgery, corrective osteotomies, or osteosynthesis of knee fractures.
- Patients who are drug addicts, alcoholics, suffer from psychiatric disorders, or have any clinical conditions that could compromise the success of the questionnaire.
- Patients with orthopedic conditions of other origins
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 |
|---|---|---|
| PROMS submitionKOOS ACL submission to validate and transalte the scale for italian people | Other | – |
Primary outcome
validated translation and cultural adaptation of the KOOS-ACL scale in Italian.
Time frame: 18 months
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 4 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Scale Reliability Validity and ACL Injury, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Feb 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validated translation and cultural adaptation of the KOOS-ACL scale in Italian. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2026.