An observational study in ACL Injury, sponsored by Stefano Zaffagnini. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Stefano Zaffagnini · Observational
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.
The literature presents a number of studies on the reconstruction of the anterior cruciate ligament, as well as numerous registers, but the identification of factors and parameters determining the clinical outcomes remains largely debated. The study aims to offer new elements to analyze this treatment and potentially identify the factors responsible for the outcomes and the factors useful to optimize the clinical outcome in the future. In fact, in addition to collect patient data in terms of features and clinical-functional status, objective data will be documented and correlated. In particular the quantification of knee laxity will be performed using an innovative device based on the use of inertial sensors (a methodology recently developed and already validated at the Istituto Ortopedico Rizzoli). The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). These patients will be followed and evaluated preoperatively, at 6 months and at 1, 2 and 5 years after surgery during a clinical visit or a telephone interview. Such evaluations will include the submission of questionnaires to determine the patient's functional symptoms and also knee joint assessment during a medical examination to quantify the knee joint stability.
Moreover, the following clinical scores will be adopted: IKDC-subjective, IKDC-objective, SF12, Marxs, Koos, Tegner, VAS for pain assessment, EQ-VAS for overall health status assessment. Also it will be recorded the lapse of time for returning to work and sports, the degree of patient satisfaction,the adverse events, the failures and any new treatments on the same site.
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 98 across 153 observational studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →Stefano Zaffagnini is the lead sponsor of 13 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with ACL lesions and undergoing to surgical ACL reconstruction
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgical ACL reconstruction
Knee Laxity Assessment
Laxity Evaluation with KiRA device
Time frame: 5 years
SF12 Score
The SF-12v2 is an abbreviated version of the SF-36. SF-36 is the best-known and most widely used measure of health-related quality of life in the international literature. It measures different health concepts through 36 multiple-choice questions, data are aggregated into 8 scales investigating: physical activity, role and physical health, physical pain, Health in general, vitality, social activities, role and emotional state, mental health, a question on change in health status during the last year is also added.
Time frame: 5 years
Marx Activity Rating Score
The Marx Scale consists of four questions concerning four activities or actions: running, cutting, deceleration, and pivoting. The patient or survey respondent is asked to report on the frequency with which they performed the activity in their healthiest state within the past year.
Time frame: 5 years
KOOS Score
KOOS SCORE consists of 5 subscales and covers: pain (9 items), symptoms (7 items, two of which are related to stiffness), functions and activities of daily living (17 items), physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items). Each question is scored from 0 to 4, where 0 indicates "no difficulty" and 4 "severe difficulty. Score range 0-100 for each subscale
Time frame: 5 years
IKDC Score
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function.
Time frame: 5 years
VAS Score
VAS is a visual analogue scale consisting of a range scale (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable"
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2020 (actual). Primary completion is estimated for Dec 2030, 120 months after the start.
Of 73 non-industry observational studies under Anterior Cruciate Ligament Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 167. This study's planned 120 months is above that.
Counting every sponsor, half of 82 studies reached it within 37 months; a quarter within 13 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
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Anterior Cruciate Ligament Injuries →
Stefano Zaffagnini