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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00492609

Enrollment

285

Registered

2007-06-27

Start date

2006-05-31

Completion date

2008-04-30

Last updated

2009-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament, Arthroscopy, Knee Injuries

Keywords

Surgery, Navigation, ACL, IKDC, comparative study

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* First knee surgery * Patients more than 18 years old

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
IKDC SCORE AT ONE YEAR	ONE YEAR

Secondary

Measure	Time frame
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

Countries

France

Outcome results