Medical and Economical Evaluation of Computer-assisted Reconstruction of the ACL
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Injuries
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 285
- Locations
- 1
- Primary Endpoint
- IKDC SCORE AT ONE YEAR
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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).
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
Investigators
Eligibility 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
Outcomes
Primary Outcomes
IKDC SCORE AT ONE YEAR
Time Frame: ONE YEAR
Secondary Outcomes
- 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)