Actively Recruiting

Age: 18Years - 60Years
All Genders
ID03441659

Anterior Cruciate Ligament Reconstruction: Clinical Outcome at Middle and Long Term Follow-Up

Led by Stefano Zaffagnini · Updated on 2026-02-02

1000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients undergoing surgical reconstruction of the anterior cruciate ligament (ACL) to better understand the factors that influence clinical outcomes after surgery. The study aims to analyze various patient features and clinical-functional statuses to identify elements that may help optimize treatment results in the future. It involves long-term follow-up assessments to gather data on patients' knee stability and functional symptoms. Patients will receive surgical ACL reconstruction and be monitored before the surgery and then at 6 months, 1 year, 2 years, and 5 years after the operation. These follow-ups will include clinical visits or telephone interviews. The study uses an innovative device with inertial sensors to measure knee laxity objectively, alongside several clinical scores such as IKDC, SF12, Marxs, Koos, Tegner, and VAS for pain and overall health. During each evaluation, patients will complete questionnaires to report functional symptoms, and their knee joint stability will be medically examined. The study will also record the time it takes for patients to return to work and sports, their satisfaction levels, any adverse events, treatment failures, and additional interventions on the same knee. The primary outcome is knee laxity measured at 5 years, with secondary outcomes including multiple clinical scores to assess overall function and pain.

CONDITIONS

Brief Title

ACL Reconstruction: Clinical Outcome

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who have provided informed written consent
  • Patients aged between 18 and 60
  • Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 1 week

Participants undergo surgical reconstruction of the anterior cruciate ligament (ACL) followed by immediate post-operative care.

1 surgery visit

Post-operative Follow-up

Duration - 5 years

Participants are followed and evaluated at multiple timepoints after surgery to assess knee function, stability, and other clinical outcomes.

Clinical visits or telephone interviews at 6 months, 1 year, 2 years, and 5 years after surgery

Trial Site Locations

Total: 1 location

1

Stefano Zaffagnini

Bologna, Italia, Italy

Actively Recruiting

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Research Team

S

Stefano Zaffagnini, MD

R

Roberta Licciardi, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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