Individualized Anterior Cruciate Ligament Versus Conventional Reconstruction

Anterior Cruciate Ligament Injuries Clinical Trial

— IACLR  

Official title:

Anterior Cruciate Ligament Surgical Reconstruction Based on Individualized Musculoskeletal Models: a Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04366362
• Other study ID #: GC1
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: April 2023

Study information

• Verified date: November 2021
• Source: Larissa University Hospital
• Contact: Georgios Chalatsis, MD
• Phone: 00306977992086
• Email: ghalatsis[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomised prospective control trial comparing the efficiency of a more individualized approach in ACL reconstruction with the help of neuromuscular computer models with traditional ACL reconstruction practices.

Description:

Until now the ACL reconstruction was based on the surgeon's experience. An individualised ACL reconstruction is customized based on each patient's special characteristics. Preoperative and intraoperative evaluation of the native ACL (both anteromedial and posterolateral bundles), knee anatomy and function, level of activity and generalised ligamentous laxity are assessed. Femoral and tibial tunnels should be placed in their anatomical location accounting for both the native ACL insertion site and bony landmarks. Two groups will be created, one with patients undergoing ACL reconstruction based on a surgeon's experience and one based on a more individualised approach according to the particular characteristics of each patient separately. In addition, patients in the second group will undergo ACL reconstruction with the use of Computer Assisted System (Navigation).

Preoperatively and postoperatively, the patients will be assessed with the KT2000 system, the KOOS (Knee injury and Osteoarthritis Outcome), the Tegner- Lysholm Knee scoring system and the IKDC (International Knee Documentation Committee). Additionally, all patient will be examined for their knee function with the use of a 3D gait analysis system.

The follow-up examination will take place 6 and 12 months after the surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients with ACL rupture undergoing ACL reconstruction surgery with closed epiphyses, younger than 45 years old

Exclusion Criteria:

• No previous surgery in the knee (except partial meniscectomy), no major systematic pathology

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

Procedure:
• Individualised ACL reconstruction
ACL reconstruction based on anatomical and functional distinctiveness of each patient separately
• Conventional ACL reconstruction
ACL reconstruction based on surgeons experience without taking into account any other patients characteristics

Locations

Country	Name	City	State
Greece	Michael Hantes	Larissa

Sponsors (2)

Lead Sponsor	Collaborator
Larissa University Hospital	University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the change of stability of the operated knee between the two groups from Baseline until 1 year post-operation	Participants in two groups will be assessed with KT2000 arthrometer before and after ACL reconstruction regarding knee stability. Additionally knee kinematics and gait analysis before and after the ACL reconstruction will be compared between the two groups in a gait analysis lab.	Baseline and 1 year post operation
Secondary	Compare the change from Baseline between the patients of the two groups in KOOS (Knee Injury & Osteoarthritis Outcome) from the baseline until 1 year post operation	Originally published in 1998 in The Journal of Orthopaedic and Sports Physical Therapy, the Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.	Baseline and 1 year post operation
Secondary	Compare the change from Baseline between the patients of the two groups in IKDC (International Knee Documentation Committee Subjective Knee Form) from the baseline until 1 year post operation.	the International Knee Documentation Committee Subjective Knee Form (IKDC) was designed to assess patients with a variety of knee disorders including ligamentous and meniscal injuries as well as patellofemoral pain and osteoarthritis. The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).	Baseline and 1 year post operation
Secondary	Compare the change from Baseline between the patients of the two groups in Tegner Lysholm Knee Scoring Scale from the baseline until 1 year post operation.	Lysholm Knee Scoring Scale was designed to be used for evaluating outcomes of knee ligament surgery, particularly for symptoms related to instability. The Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).	Baseline and 1 year post operation
Secondary	Compare the post operation MRI of the 2 groups	Evaluate tunnel positioning in femur and tibia and the graft integration and compare them between the 2 groups.	1 year post operation