ACL InjuryRIC-ACLNCT03441659
ACL Reconstruction: Clinical Outcome
An observational study of ACL Injury, run by Stefano Zaffagnini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- ACL reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 17 Dec 2020to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with ACL lesions and undergoing to surgical ACL reconstruction
Who may be able to join
- 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)
Who cannot join
- Patients unable to understand and to want;
- Patients who have not signed informed consent;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Stefano Zaffagnini
Bologna, Italia
Stefano Zaffagnini, MD, 051 6366075, stefano.zaffagnini@unibo.it
About this study
Official title: Anterior Cruciate Ligament Reconstruction: Clinical Outcome at Middle and Long Term Follow-Up
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.
Read the detailed description
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.
- Conditions
- ACL Injury
- Being tested
- ACL reconstruction
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstructionProcedure or surgery
Surgical ACL reconstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Laxity Assessment
Laxity Evaluation with KiRA device
Measured: 5 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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"
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start17 Dec 2020
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stefano Zaffagnini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441659
- Sponsor's protocol ID
- 0007043
- Acronym
- RIC-ACL
- Status last verified
- Jul 2026
- First submitted
- 29 Aug 2017
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Cruciate Ligament Reconstruction: Clinical Outcome at Middle and Long Term Follow-Up
- ClinicalTrials.gov ID
- NCT03441659
- Acronym / sponsor ID
- RIC-ACL / 0007043
- Conditions
- ACL Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Stefano ZaffagniniUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with ACL lesions and undergoing to surgical ACL reconstruction
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Patients unable to understand and to want;
- Patients who have not signed informed consent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL reconstructionSurgical ACL reconstruction | Procedure or surgery | – |
Primary outcome
Knee Laxity Assessment
Time frame: 5 years
Laxity Evaluation with KiRA device
5 secondary outcomes
SF12 Score
Time frame: 5 years
Marx Activity Rating Score
Time frame: 5 years
KOOS Score
Time frame: 5 years
IKDC Score
Time frame: 5 years
VAS Score
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Injury, run by Stefano Zaffagnini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Zaffagnini, MD (0516366567, stefano.zaffagnini@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Laxity Assessment (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.