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Not yet recruiting NCT07386405

Validation and Cultural Adaptation of the KOOS-ACL Scale for the Italian Population

Observational Scale Reliability Validity ACL Injury Validation and Cultural Adaptation of a Scale PROMs

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PROMS submition.
Who it may be relevant to
Registry conditions: Scale Reliability Validity, ACL Injury, Validation and Cultural Adaptation of a Scale, PROMs. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Italian Version of KOOS-ACL (Knee Injury and Osteoarthritis Outcomes Score - Anterior Cruciate Ligament): Translation, Cross-cultural Adaptation and Validation

Overview

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.

Interventions

  • Other PROMS submition
    KOOS ACL submission to validate and transalte the scale for italian people

Primary outcome measures

  • validated translation and cultural adaptation of the KOOS-ACL scale in Italian. [Time frame: 18 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 1 center
  • Istituto Clinico San Siro — Milan

Identifiers

NCT: NCT07386405 · KOOS-ACL Validation (VACKP)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗