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

November 10, 2009 updated by: University Hospital, Grenoble

Medical and Economical Evaluation of Computer-assisted Reconstruction of the 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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

285

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • University hospital of Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with first knee surgery, available to control's visits at 6 months and one year

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
PATIENTS WITH COMPUTER-ASSISTED
2
PATIENTS WITHOUT COMPUTER-ASSISTED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IKDC SCORE AT ONE YEAR
Time Frame: ONE YEAR
ONE YEAR

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Netherlands: Ministry of Health, Welfare and Sports

Investigators

  • Principal Investigator: Plaweski AP Stephane, PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

June 26, 2007

First Submitted That Met QC Criteria

June 26, 2007

First Posted (Estimate)

June 27, 2007

Study Record Updates

Last Update Posted (Estimate)

November 11, 2009

Last Update Submitted That Met QC Criteria

November 10, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 05 47
  • PRAXIM SOCIETY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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