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| Name | Class |
|---|---|
| Clinical Trial Unit Ente Ospedaliero Cantonale | OTHER |
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This is a prospective and randomized trial to compare two different techniques used in normal practice for the reconstruction of the anterior cruciate ligament in arthroscopy.
The experimental group (group 1) will undergo a reconstruction technique where semitendinosus and gracilis will preserve their insertion at the level of the hamstring whereas in the control group (group 2) the semitendinosus and gracilis tendons will be disengaged from their insertion on the hamstring .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insertion preserving | Experimental | ACL reconstruction preserving insertion |
|
| insertion detaching | Active Comparator | ACL reconstruction detaching insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACL reconstruction preserving insertion | Procedure | Anterior cruciate ligament reconstruction with semitendinosus and gracilis, preserving their insertion at the level of the hamstring. |
| Measure | Description | Time Frame |
|---|---|---|
| Graft integration by the Signal / Noise Quotient (SNQ) at 6 months | Signal intensity of the graft evaluated by the Signal / Noise Quotient (SNQ) during MRI 3 Tesla | 6 months after ACL reconstruction intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Graft integration by the Signal / Noise Quotient (SNQ) at 3 and 12 months | Signal intensity of the graft evaluated by the Signal / Noise Quotient (SNQ) during MRI 3 Tesla | 3, 12 months after ACL reconstruction intervention |
| Right anatomical graft position |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Decogliano, MD | EOC - Unità Traumatologia e Ortopedia - ORL | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Ortopedico Rizzoli | Bologna | Italy | ||||
| EOC - Unità Traumatologia e Ortopedia ORL |
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| ACL reconstruction detaching insertion | Procedure | Anterior cruciate ligament reconstruction with semitendinosus and gracilis tendons completely detached from their insertion at the hamstring. |
|
Evaluation of right anatomical graft position by MRI 3 TESLA |
| 12 months after ACL reconstruction intervention |
| Anterior tibial translation | Anterior tibial translation will be measured in millimeters using the arthrometer Rolimeter | 3, 6, 12 months after ACL reconstruction intervention |
| Anterior knee joint instability | Anterior knee joint instability will be measured by the device KiRA (Kinematic Rapid Assessment) by the parameters of the pivot-shift test | 3, 6, 12 months after ACL reconstruction intervention |
| IKDC (International Knee Documentation Committee) questionnaire | Test to evaluate post-surgery instability with a scores range from 0 points to 100 points; patients report symptoms, sports and daily living activities | 3, 6, 12 months after ACL reconstruction intervention |
| Tegner activity scale | Test to evaluate post-surgery instability with a scores range from 0 points to 10 points; patients describe their current level of activity and that before injury. | 3, 6, 12 months after ACL reconstruction intervention |
| Lugano |
| Switzerland |