ACL InjuryNCT06194682
Anterior Cruciate Ligament Study
An observational study of ACL Injury and ACL, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
This retrospective, prospective observational study aims to evaluate the epidemiology and rate of anterior cruciate ligament re- rupture after surgery in patients treated from January 2020 to December 2030 by recording both clinically and radiographically ligament reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ACL Injury, ACL, Anterior Cruciate Ligament Rupture
- What is being tested?
- Anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 370 participants
- Where
- 1 siteItaly
- Study dates
- 6 Dec 2023to 31 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone and will undergo anterior cruciate ligament reconstruction surgery at the CASCO Team between January 2020 and December 2030. Clinical data, any questionnaires, scores, and radiographic parameters were collected at the same time as the visits and prescribed procedures according to the clinical routine of the department. No additional services will be prescribed by virtue of participation in this study
Who may be able to join
- - Males and females- attained skeletal maturity
- 18-65 inclusive
- Patients operated on anterior cruciate ligament reconstruction surgery at the Hospital's Casco unit from 2010 to 2030
- Signature informed consent for patients who will be operated on in the prospective phase (from CE approval date to 2030)
Who cannot join
- failure to reach skeletal maturity
- Concomitant ligamentous injuries (pcl, mcl, lcl)
- Neuropsychiatric illness, developmental disorders
- Pregnant women through self-declaration or breastfeeding
- Minors
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
IRCCS Istituto Ortopedico Galeazzi
Milan, 20100
Riccardo D'Ambrosi, MD, +393397066151, riccardo.dambrosi@hotmail.it
About this study
Official title: "Valutazione Dell'Epidemiologia e Dei Risultati Clinici Nel Trattamento Artroscopico Delle Lesioni Del Legamento Crociato Anteriore"
This retrospective, prospective observational study aims to evaluate the epidemiology and rate of anterior cruciate ligament re- rupture after surgery in patients treated from January 2020 to December 2030 by recording both clinically and radiographically ligament reconstruction.
The primary outcome is the rate of rupture of the anterior cruciate ligament as measured by the Lachmann test in which a positive value for re-rupture is an anterior translation of the tibia greater than 10mm relative to the femur Secondary Objectives: Verify predisposing factors to anterior cruciate ligament injuries (so anatomical factors such as tibial slope, trochlear groove), demographic factors (age, sex, weight, sports played), and the rate of return to sports, quality of life via questionnaires, and arthrosis at the operated knee
- Conditions
- ACL Injury, ACL, Anterior Cruciate Ligament Rupture
- Being tested
- Anterior cruciate ligament 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.
Anterior cruciate ligament reconstructionProcedure or surgery
Anterior cruciate ligament arthroscopic reconstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Rerupture rate
rate of rerupture rare evaluated with anterior tibial translation
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start6 Dec 2023
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 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
- Other
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194682
- Sponsor's protocol ID
- ACL(L2104)
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Valutazione Dell'Epidemiologia e Dei Risultati Clinici Nel Trattamento Artroscopico Delle Lesioni Del Legamento Crociato Anteriore"
- ClinicalTrials.gov ID
- NCT06194682
- Acronym / sponsor ID
- ACL(L2104)
- Conditions
- ACL Injury, ACL, Anterior Cruciate Ligament Rupture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Jan 2024 (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.
This retrospective, prospective observational study aims to evaluate the epidemiology and rate of anterior cruciate ligament re- rupture after surgery in patients treated from January 2020 to December 2030 by recording both clinically and radiographically ligament reconstruction.
The primary outcome is the rate of rupture of the anterior cruciate ligament as measured by the Lachmann test in which a positive value for re-rupture is an anterior translation of the tibia greater than 10mm relative to the femur Secondary Objectives: Verify predisposing factors to anterior cruciate ligament injuries (so anatomical factors such as tibial slope, trochlear groove), demographic factors (age, sex, weight, sports played), and the rate of return to sports, quality of life via questionnaires, and arthrosis at the operated knee
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone and will undergo anterior cruciate ligament reconstruction surgery at the CASCO Team between January 2020 and December 2030. Clinical data, any questionnaires, scores, and radiographic parameters were collected at the same time as the visits and prescribed procedures according to the clinical routine of the department. No additional services will be prescribed by virtue of participation in this study
Key inclusion criteria (4 listed)
- - Males and females- attained skeletal maturity
- 18-65 inclusive
- Patients operated on anterior cruciate ligament reconstruction surgery at the Hospital's Casco unit from 2010 to 2030
- Signature informed consent for patients who will be operated on in the prospective phase (from CE approval date to 2030)
Key exclusion criteria (5 listed)
- failure to reach skeletal maturity
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 |
|---|---|---|
| Anterior cruciate ligament reconstructionAnterior cruciate ligament arthroscopic reconstruction | Procedure or surgery | – |
Primary outcome
Rerupture rate
Time frame: 10 years
rate of rerupture rare evaluated with anterior tibial translation
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 8 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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 and ACL, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 4 inclusion and 5 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 8 Jan 2024. 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 Riccard D'Ambrosi, MD (+393397066151, riccardo.dambrosi@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rerupture rate (time frame: 10 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 8 Jan 2024.