Clinical trial Recruiting at 1 site Observational Ages 18 to 60

Monitoring outcomes after ACL reconstruction surgery

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

Run by Istituto Ortopedico Rizzoli · NCT03441659 · Data updated 2026-11-12

This study is tracking how well people recover after ACL surgery over five years to see what helps them heal better.

Quick facts

Study typeObservational
Ages18 Years to 60 Years
SexAll
Enrollment1000 (estimated)
SponsorIstituto Ortopedico Rizzoli
Academic / other
Locations1 site (Bologna, Italia)
StatusRecruiting
StartedDecember 17, 2020
Main results expectedDecember 2030
Study endsDecember 2030
Registry record updatedJuly 9, 2026
Trial IDNCT03441659 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 18 to 60 who are scheduled for ACL reconstruction surgery and can provide informed consent.

Probably not a fit

Patients who are unable to understand the study requirements or who do not provide informed consent will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study includes patients undergoing surgical reconstruction of the anterior cruciate ligament (ACL) and aims to evaluate their clinical outcomes over time. Participants will be assessed preoperatively and at 6 months, 1 year, 2 years, and 5 years post-surgery through clinical visits or telephone interviews. The study will utilize questionnaires to gauge functional symptoms and will objectively measure knee stability using an innovative device with inertial sensors. By analyzing various clinical scores and patient data, the study seeks to identify factors influencing recovery and optimize future treatment strategies.

Why it matters

Potential benefit: If successful, this study could enhance understanding of ACL reconstruction outcomes and improve rehabilitation protocols for patients.

How similar studies have gone: Previous studies on ACL reconstruction have shown varying outcomes, but this study's innovative approach to measuring knee stability is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

1. Patients unable to understand and to want;
2. Patients who have not signed informed consent;

Where it's running

  • Stefano Zaffagnini
    Bologna, Italia, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.