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

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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Medical and Economical Evaluation of Computer-assisted Reconstruction of the ACL

Conditions
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Knee Injuries, Anterior Cruciate Ligament, Arthroscopy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First knee surgery Patients more than 18 years old Exclusion Criteria: Knee surgery already done Patients unable to understand informed consent sheet

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>PATIENTS WITH COMPUTER-ASSISTED | |
| 2<br>PATIENTS WITHOUT COMPUTER-ASSISTED | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKDC SCORE AT ONE YEAR |  | ONE YEAR | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, Surgery, Navigation, IKDC, comparative study