Skip to main content
OpenTrials
Completed

NCT Number: NCT00492609

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Injuries Anterior Cruciate Ligament Arthroscopy Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Grenoble

Grenoble, 38043, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First knee surgery
  • Patients more than 18 years old

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. IKDC SCORE AT ONE YEAR

    Time frame: ONE YEAR

Secondary outcomes

  1. COMPARISON IKDC SCORE BENEFIT AT ONE YEAR

    Time frame: one year

  2. functionnal regaining between two groups at one year

    Time frame: one year

  3. evaluate the surgeons' learning in the groups of patients with computer assisted

    Time frame: time of surgery, one year

  4. evaluate hospitals' parameters in two groups

    Time frame: time of surgery, time of hospitalization

  5. evaluate frequency of complication after surgery (infectious, thrombosis, scar)

    Time frame: 6 months, one year

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Netherlands: Ministry of Health, Welfare and Sports

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2008
First posted
Jun 27, 2007
Registry last updated
Nov 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.