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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00465-36 | Other Identifier | RCB number |
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Patient enrolment proved to be more difficult than foreseen and was stopped at 46 inclusions.
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The main objective of this study is to compare, using MRI measures with a specialized splint, the persistent rotatory laxity after anterior cruciate ligament reconstruction using single bundle and double bundle surgical techniques, between the seventh and eighth months after surgery, and for different degrees of knee flexion (0 °, 20 °, 40 °, 60 °).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Bundle | Active Comparator | These patients are operated using a single bundle technique. |
|
| Double bundle | Experimental | These patients are operated using a double bundle technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single bundle anterior cruciate ligament reconstruction | Procedure | Single bundle anterior cruciate ligamentoplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Residual rotational laxity during MRI | Residual rotational laxity is defined as the difference between the operated knee and the non-operated knee for "D", where D is the distance between the posterior tibial cortex and the center of the circle which forms the lateral femoral condyle. D will be evaluated at 4 angles of flexion (0°, 20°, 40° and 60°) and evaluated as a repeated measure. | 7-8 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Lysholm score | 7-8 months | |
| International Knee Documentation Committee score | 7-8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Marchand, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Nîmes | Nîmes | Gard | 30029 | France |
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| Double bundle anterior cruciate ligament reconstruction | Procedure | Double bundle anterior cruciate ligamentoplasty |
|
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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