Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Among High Demand Patients
- Conditions
- Anterior Cruciate Ligament Tear
- Interventions
- Procedure: Isolated anterior cruciate ligament reconstruction onlyProcedure: Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis
- Registration Number
- NCT05962580
- Lead Sponsor
- Ain Shams University
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
-
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:
- History of knee traumatic event.
- Clinical examination ( positive Lachman test and pivot shift test).
- Radiological evidence of ACL tear by MRI.
-
patient with high pivot shift test.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis Isolated anterior cruciate ligament reconstruction only Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction only Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction with modified Lemiere technique for extra-articular tenodesis
- Primary Outcome Measures
Name Time Method failure rate one year follow up retear of ACL graft confirmed by clinical examination and MRI
- Secondary Outcome Measures
Name Time Method antero-posterior instability measure at 3,6,9 and 12 months measure AP instability by KT1000 lachmeter for injured and non injured knee
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)
side to side KT 1000 lachmeter difference one year follow up measure side to side KT 1000 lachmeter difference by (injured - noninjured)
Trial Locations
- Locations (1)
Ahmed Abdel Salam Abdel Halim
🇪🇬Cairo, Abbasia, Egypt