- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00492609
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
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Grenoble, France, 38043
- University hospital of Grenoble
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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 |
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1
PATIENTS WITH COMPUTER-ASSISTED
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2
PATIENTS WITHOUT COMPUTER-ASSISTED
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
IKDC SCORE AT ONE YEAR
Time Frame: ONE YEAR
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ONE YEAR
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
COMPARISON IKDC SCORE BENEFIT AT ONE YEAR
Time Frame: one year
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one year
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functionnal regaining between two groups at one year
Time Frame: one year
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one year
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evaluate the surgeons' learning in the groups of patients with computer assisted
Time Frame: time of surgery, one year
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time of surgery, one year
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evaluate hospitals' parameters in two groups
Time Frame: time of surgery, time of hospitalization
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time of surgery, time of hospitalization
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evaluate frequency of complication after surgery (infectious, thrombosis, scar)
Time Frame: 6 months, one year
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6 months, one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
- Beaufils P, Lerat JL. [Navigation for knee surgery]. Rev Chir Orthop Reparatrice Appar Mot. 2006 Sep;92(5 Suppl):2S199-2S207. No abstract available. French.
- Plaweski S, Cazal J, Rosell P, Merloz P. Anterior cruciate ligament reconstruction using navigation: a comparative study on 60 patients. Am J Sports Med. 2006 Apr;34(4):542-52. doi: 10.1177/0363546505281799.
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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