Individualized Anterior Cruciate Ligament Versus Conventional Reconstruction (IACLR)

Larissa University Hospital

Status: Unknown

Conditions: Anterior Cruciate Ligament Injuries

Treatments: Procedure: Individualised ACL reconstruction; Procedure: Conventional ACL reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT04366362

GC1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 14 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Convetional reconstruction group

Active Comparator group

Description:

Patients will undergo ACL reconstruction based on conventional ACL surgery

Treatment:

Procedure: Conventional ACL reconstruction

Individualised reconstruction group

Experimental group

Description:

Patients will undergo ACL reconstruction based on their special anatomical and functional characteristics and with the use of a navigation system

Treatment:

Procedure: Individualised ACL reconstruction