Medical and Economical Evaluation of Computer-assisted Reconstruction of the Anterior Cruciate Ligament (ACL)

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Knee Injuries

Arthroscopy

Anterior Cruciate Ligament

Study type

Observational

Funder types

Other

Identifiers

NCT00492609

DCIC 05 47

PRAXIM SOCIETY

Details and patient eligibility

About

A poor outcome in anterior cruciate ligament (ACL) reconstruction is often related to tunnel position. The researchers believe that improving the accuracy of tunnel position will lead to an improved outcome in ACL surgery. The researchers' purpose is to perform a controlled study on a series of 500 patients in two groups: group I (250 cases) using conventional instrumentation and group II (250 cases) using navigation (Surgetics ACL Julliard protocol).

Full description

This study compares the percentage of patients in 2 groups (full success) at 1 year of follow up. The results were evaluated on clinical outcome based on the IKDC (International Knee Documented Committee, subjective evaluation) form between one group using conventional instrumentation and another group using navigation.

Secondary Aims:

To compare in 2 groups:
- Gain of IKDC score at one year (based on pre-operative IKDC score)
- Evolution of IKDC subjective (pre-operative, at 12 months)
To compare performances at one year (% class A or B) in terms of initial instability measured with laximetry score
Study of the learning curve
Evaluate: lasting quality, complication rate, extra-operative time
Evaluate frequency of thrombovenous complications
Evaluate delay to return to sport