Actively Recruiting
Study on ACL Injury Surgery Outcomes with Follow-Up Over Five Years
Led by Stefano Zaffagnini · Updated on 2026-07-09
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients who will undergo surgical reconstruction of the anterior cruciate ligament ACL to better understand factors that influence clinical outcomes after this surgery. The study aims to analyze patient characteristics, clinical-functional status, and objective data to identify what affects recovery and knee stability over time. Participants will have ACL reconstruction surgery and be followed through clinical visits or telephone interviews before surgery and at 6 months, 1 year, 2 years, and 5 years afterward. Knee laxity will be quantified using a novel device with inertial sensors, and various clinical scores will be collected, including IKDC, SF12, Marxs, Koos, Tegner, and pain assessments. Throughout the study, participants will complete questionnaires evaluating functional symptoms and overall health, and undergo knee joint examinations to measure stability. Researchers will track time to return to work and sports, patient satisfaction, adverse events, failures, and any new treatments on the same knee. The primary outcome is knee laxity assessment at 5 years, with additional measures of physical activity, pain, and quality of life collected over the same period.
CONDITIONS
Brief Title
ACL Reconstruction: Clinical Outcome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Patients unable to understand and to want
- Patients who have not signed informed consent
Research Team
S
Stefano Zaffagnini, MD
R
Roberta Licciardi, MD
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