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

Completed

• Conditions: Knee Injuries; Anterior Cruciate Ligament; Arthroscopy

• Registration Number: NCT00492609
• Lead Sponsor: University Hospital, Grenoble

Brief 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

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-06-26
• Study First Submitted QC: 2007-06-26
• Study First Posted: 2007-06-27
• Study Completion: 2008-04
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-10
• Last Update Posted: 2009-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

Inclusion Criteria

• First knee surgery
• Patients more than 18 years old

Exclusion Criteria

• Knee surgery already done
• Patients unable to understand informed consent sheet

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IKDC SCORE AT ONE YEAR	ONE YEAR

Secondary Outcome Measures

Name	Time	Method
COMPARISON IKDC SCORE BENEFIT AT ONE YEAR	one year
functionnal regaining between two groups at one year	one year
evaluate the surgeons' learning in the groups of patients with computer assisted	time of surgery, one year
evaluate hospitals' parameters in two groups	time of surgery, time of hospitalization
evaluate frequency of complication after surgery (infectious, thrombosis, scar)	6 months, one year

Trial Locations

Locations (1)

University Hospital of Grenoble; 🇫🇷 Grenoble, France