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

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ClinicalTrials.gov Identifier: NCT00492609
Recruitment Status : Completed
First Posted : June 27, 2007
Last Update Posted : November 11, 2009
Sponsor:
Collaborator:
Netherlands: Ministry of Health, Welfare and Sports
Information provided by:
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).

Condition or disease
Knee Injuries Anterior Cruciate Ligament Arthroscopy

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
Actual Enrollment : 285 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medical and Economical Evaluation of Computer-assisted Reconstruction of the ACL
Study Start Date : May 2006
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. IKDC SCORE AT ONE YEAR [ Time Frame: ONE YEAR ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with first knee surgery, available to control's visits at 6 months and one year
Criteria

Inclusion Criteria:

  • First knee surgery
  • Patients more than 18 years old

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492609


Locations
France
University Hospital of Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Netherlands: Ministry of Health, Welfare and Sports
Investigators
Principal Investigator: Plaweski AP Stephane, PhD University Hospital, Grenoble

Publications:
Responsible Party: Dr Plaweski, Grenoble University Hospital
ClinicalTrials.gov Identifier: NCT00492609     History of Changes
Other Study ID Numbers: DCIC 05 47
PRAXIM SOCIETY
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: November 11, 2009
Last Verified: November 2009

Keywords provided by University Hospital, Grenoble:
Surgery
Navigation
ACL
IKDC
comparative study

Additional relevant MeSH terms:
Knee Injuries
Leg Injuries
Wounds and Injuries