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

This study has been completed.
Sponsor:
Collaborator:
Netherlands: Ministry of Health, Welfare and Sports
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00492609
First received: June 26, 2007
Last updated: November 10, 2009
Last verified: November 2009

June 26, 2007
November 10, 2009
May 2006
Not Provided
IKDC SCORE AT ONE YEAR [ Time Frame: ONE YEAR ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00492609 on ClinicalTrials.gov Archive Site
  • COMPARISON IKDC SCORE BENEFIT AT ONE YEAR [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • functionnal regaining between two groups at one year [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • evaluate the surgeons' learning in the groups of patients with computer assisted [ Time Frame: time of surgery, one year ] [ Designated as safety issue: Yes ]
  • evaluate hospitals' parameters in two groups [ Time Frame: time of surgery, time of hospitalization ] [ Designated as safety issue: Yes ]
  • evaluate frequency of complication after surgery (infectious, thrombosis, scar) [ Time Frame: 6 months, one year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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

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).

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Knee Injuries
  • Anterior Cruciate Ligament
  • Arthroscopy
Not Provided
  • 1
    PATIENTS WITH COMPUTER-ASSISTED
  • 2
    PATIENTS WITHOUT COMPUTER-ASSISTED

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
285
April 2008
Not Provided

Inclusion Criteria:

  • First knee surgery
  • Patients more than 18 years old

Exclusion Criteria:

  • Knee surgery already done
  • Patients unable to understand informed consent sheet
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00492609
DCIC 05 47, PRAXIM SOCIETY
Yes
Dr Plaweski, Grenoble University Hospital
University Hospital, Grenoble
Netherlands: Ministry of Health, Welfare and Sports
Principal Investigator: Plaweski AP Stephane, PhD University Hospital, Grenoble
University Hospital, Grenoble
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP