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Clinical Trial Summary

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).


Clinical Trial 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 ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00492609
Study type Observational
Source University Hospital, Grenoble
Contact
Status Completed
Phase N/A
Start date May 2006
Completion date April 2008

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