NCT00492609

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

Medical and Economical Evaluation of Computer-assisted Reconstruction of the ACL

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 285 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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

Conditions

• Knee Injuries
• Anterior Cruciate Ligament
• Arthroscopy

Timeline

• Start date: 2006-05-01
• Completion: 2008-04-01
• First posted: 2007-06-27
• Last updated: 2009-11-11

Locations

1 site across 1 country: France