Anterior Cruciate Ligament Tear
Conditions
Keywords
anterior cruciate ligament tear, anterolateral instability, retear, extra articular tenodesis
Brief summary
Anterior Cruciate Ligament Reconstruction with and without Lateral Extra-Articular Tenodesis between high demand patients
Detailed description
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)
Interventions
PROCEDUREIsolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis
Anatomical single bundle ACLR with modified Lemiere technique
PROCEDUREIsolated anterior cruciate ligament reconstruction only
arthroscopic anatomical single bundle ACL Reconstruction
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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: 1. History of knee traumatic event. 2. Clinical examination ( positive Lachman test and pivot shift test). 3. Radiological evidence of ACL tear by MRI. * patient with high pivot shift test.
Exclusion criteria
* Generalized ligamentous laxity. * Other intra or extra articular knee injuries. * Previous ACL surgery on the affected knee. * Bilateral ACL injuries. * Significant Articular surface injury. * Medical comorbidities * Patients with malalignment ( genu varum, genu valgum or genu recurvatum ) * Neuromuscular disorders * Knee arthritic changes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| failure rate | one year follow up | retear of ACL graft confirmed by clinical examination and MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International knee documentation committee score (IKDC) | at 3,6,9,12 months | 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) |
| Lysholm score | at 3,6,9,12 months | 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) |
| antero-posterior instability measure | at 3,6,9 and 12 months | measure AP instability by KT1000 lachmeter for injured and non injured knee |
| side to side KT 1000 lachmeter difference | one year follow up | measure side to side KT 1000 lachmeter difference by (injured - noninjured) |
Countries
Egypt
Outcome results
None listed