Anterior Cruciate Ligament Study

NCT06194682 | Recruiting

• 1 other identifier: ACL(L2104)
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Rerupture rate

  rate of rerupture rare evaluated with anterior tibial translation

  10 years

Interventions

Anterior cruciate ligament reconstruction PROCEDURE

Anterior cruciate ligament arthroscopic reconstruction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• \- Males and females- attained skeletal maturity
• 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)

You may not qualify if:

• failure to reach skeletal maturity
• Concomitant ligamentous injuries (pcl, mcl, lcl)
• Neuropsychiatric illness, developmental disorders
• Pregnant women through self-declaration or breastfeeding
• Minors

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20100, Italy

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Central Study Contacts

Riccard D'Ambrosi, MD

CONTACT

+393397066151; riccardo.dambrosi@hotmail.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: December 6, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 8, 2024

Record last verified: 2023-12

Locations

IT (1)