NCT04366362

Individualized Anterior Cruciate Ligament Versus Conventional Reconstruction

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Larissa University Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Anterior Cruciate Ligament Injuries

Interventions

Type	Name	Description
PROCEDURE	Individualised ACL reconstruction	ACL reconstruction based on anatomical and functional distinctiveness of each patient separately
PROCEDURE	Conventional ACL reconstruction	ACL reconstruction based on surgeons experience without taking into account any other patients characteristics

Timeline

• Start date: 2020-03-02
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2020-04-28
• Last updated: 2021-11-18

Locations

1 site across 1 country: Greece