NCT07386405

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jan 2026Jul 2027

Study Start

First participant enrolled

January 19, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 27, 2026

Last Update Submit

January 27, 2026

Conditions

Scale Reliability ValidityACL InjuryPROMsValidation and Cultural Adaptation of a Scale

Keywords

scale reliabilityACLKOOS-ACLPROMs

Outcome Measures

Primary Outcomes (1)

  • validated translation and cultural adaptation of the KOOS-ACL scale in Italian.

    18 months

Interventions

PROMS submitionOTHER

KOOS ACL submission to validate and transalte the scale for italian people

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of anterior cruciate ligament injury, undergoing or being considered for ACL reconstruction surgery.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico San Siro

Milan, Italy

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 4, 2026

Study Start

January 19, 2026

Primary Completion

April 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)