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Anterior Cruciate Ligament Reconstruction with and without Lateral Extra-Articular Tenodesis between high demand patients
It is a randomized control trial comparing between isolated anterior cruciate ligament reconstruction with and without lateral extra articular tenodesis between high demand and high risk groups with high pivot regarding failure rate (primary out come) and patient reported functions score (IKDC and Lysholm)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis | Experimental | Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction with modified Lemiere technique for extra-articular tenodesis |
|
| Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis | Active Comparator | Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis | Procedure | Anatomical single bundle ACLR with modified Lemiere technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| failure rate | retear of ACL graft confirmed by clinical examination and MRI | one year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| International knee documentation committee score (IKDC) | The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms) | at 3,6,9,12 months |
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Inclusion Criteria:
High demand patients (manual workers, athletes,...etc.).
Normal average body mass index ( 18.5 - 24.9 ).
Age <40 years old.
Patients will be diagnosed as ACL tear by the following:
patient with high pivot shift test.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amr Mo Abdelhady, Professor | Faculty of medecine, Ain shams university | Study Chair |
| Mohamed Ha Sobhey, Professor | Faculty of medecine, Ain shams university | Study Director |
| Moustapha Al ElAbd, lecturer | Faculty of medecine, Ain shams university | Study Director |
| Yehia Mo Haroun, Lecturer | Faculty of medecine, Ain shams university | Study Director |
| Ahmed Ab Amer, Msc | Faculty of medecine, Ain shams university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmed Abdel Salam Abdel Halim | Cairo | Abbasia | 11539 | Egypt |
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| Isolated anterior cruciate ligament reconstruction only | Procedure | arthroscopic anatomical single bundle ACL Reconstruction |
|
| Lysholm score | The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. Physicians use this condition-specific, subjective outcome score to assess patient progress after surgery or injury to the knee. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms) | at 3,6,9,12 months |
| antero-posterior instability measure | measure AP instability by KT1000 lachmeter for injured and non injured knee | at 3,6,9 and 12 months |
| side to side KT 1000 lachmeter difference | measure side to side KT 1000 lachmeter difference by (injured - noninjured) | one year follow up |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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