Actively Recruiting
Evaluation of Epidemiology and Clinical Outcomes in Arthroscopic Treatment of Anterior Cruciate Ligament Injuries
Led by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Updated on 2024-01-08
370
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying patients who have had an anterior cruciate ligament (ACL) reconstruction surgery to understand how often the ligament re-ruptures after surgery. This observational study includes patients treated from January 2020 to December 2030 and aims to evaluate the rate of ACL re-rupture using both clinical exams and X-rays. It also seeks to identify factors that may increase the risk of ACL injuries and to assess return to sports, quality of life, and knee arthrosis. The study involves patients who have undergone arthroscopic ACL reconstruction surgery. The main focus is to measure the rate of ACL re-rupture using the Lachmann test, where a positive result is defined as an anterior tibial movement greater than 10mm compared to the femur. Researchers will also analyze anatomical and demographic factors, such as tibial slope, age, sex, weight, and sports activity, that might influence injury risk. Participants will be monitored over a period extending up to 10 years to observe the re-rupture rate and other health outcomes. Data collection will include clinical assessments, radiographic imaging, and questionnaires on quality of life and physical activity. The study aims to better understand ACL injury recurrence and recovery, with ongoing observation and follow-up through the end of 2030.
CONDITIONS
Brief Title
Anterior Cruciate Ligament Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females who have reached skeletal maturity
- Age between 18 and 65 years inclusive
- Patients who underwent anterior cruciate ligament reconstruction surgery at the Hospital's Casco unit from 2010 to 2030
- Signed informed consent for patients operated on during the prospective phase (from CE approval date to 2030)
You will not qualify if you...
- Failure to reach skeletal maturity
- Concomitant ligament injuries such as PCL, MCL, or LCL
- Neuropsychiatric illnesses or developmental disorders
- Pregnant or breastfeeding women
- Minors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Varies according to individual recovery
Participants undergo anterior cruciate ligament arthroscopic reconstruction and receive immediate post-operative care.
1 surgical procedure visit and follow-up visits as needed
Duration - Up to 10 years
Participants are monitored for clinical outcomes including rerupture rate over a period of up to 10 years after surgery.
Periodic follow-up visits depending on clinical needs
Trial Site Locations
Total: 1 location
1
IRCCS Istituto Ortopedico Galeazzi
Milan, Italy, 20100
Actively Recruiting
Research Team
R
Riccard D'Ambrosi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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