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| ID | Type | Description | Link |
|---|---|---|---|
| PRAXIM SOCIETY |
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| Name | Class |
|---|---|
| Netherlands: Ministry of Health, Welfare and Sports | OTHER_GOV |
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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).
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | PATIENTS WITH COMPUTER-ASSISTED | ||
| 2 | PATIENTS WITHOUT COMPUTER-ASSISTED |
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| Measure | Description | Time Frame |
|---|---|---|
| IKDC SCORE AT ONE YEAR | ONE YEAR |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with first knee surgery, available to control's visits at 6 months and one year
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| Name | Affiliation | Role |
|---|---|---|
| Plaweski AP Stephane, PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Grenoble | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17088785 | Background | 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. | |
| 16556753 | Background | 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. |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| 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 |