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
  Purpose

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
Knee Injuries
Anterior Cruciate Ligament
Arthroscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medical and Economical Evaluation of Computer-assisted Reconstruction of the ACL

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • IKDC SCORE AT ONE YEAR [ Time Frame: ONE YEAR ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 285
Study Start Date: May 2006
Study Completion Date: April 2008
Groups/Cohorts
1
PATIENTS WITH COMPUTER-ASSISTED
2
PATIENTS WITHOUT COMPUTER-ASSISTED

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Dr Plaweski, Grenoble University Hospital
ClinicalTrials.gov Identifier: NCT00492609     History of Changes
Other Study ID Numbers: DCIC 05 47, PRAXIM SOCIETY
Study First Received: June 26, 2007
Last Updated: November 10, 2009
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 21, 2014