NCT03441659

Brief Summary

The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively and also at 6 months and 1, 2 and 5 years after the intervention through a clinical visit or telephone interview. Such assessments will include the administration of questionnaires to determine the patient's functional symptoms and the objective examination of the knee during a medical examination to quantify its stability.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress54%
Dec 2020Dec 2030

First Submitted

Initial submission to the registry

August 29, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
2.8 years until next milestone

Study Start

First participant enrolled

December 17, 2020

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

February 2, 2026

Status Verified

June 1, 2025

Enrollment Period

10 years

First QC Date

August 29, 2017

Last Update Submit

January 29, 2026

Conditions

ACL Injury

Outcome Measures

Primary Outcomes (1)

  • Knee Laxity Assessment

    Laxity Evaluation with KiRA device

    5 years

Secondary Outcomes (5)

  • SF12 Score

    5 years

  • Marx Activity Rating Score

    5 years

  • KOOS Score

    5 years

  • IKDC Score

    5 years

  • VAS Score

    5 years

Interventions

ACL reconstructionPROCEDURE

Surgical ACL reconstruction

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with ACL lesions and undergoing to surgical ACL reconstruction

You may qualify if:

  • Patients who have provided informed written written consent;
  • Patients aged between 18 and 60;
  • Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)

You may not qualify if:

  • Patients unable to understand and to want;
  • Patients who have not signed informed consent;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stefano Zaffagnini

Bologna, Italia, Italy

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Stefano Zaffagnini, MD

CONTACT

0516366567stefano.zaffagnini@ior.it

Roberta Licciardi, MD

CONTACT

6366567roberta.licciardi@ior.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

August 29, 2017

First Posted

February 22, 2018

Study Start

December 17, 2020

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

February 2, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)