Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Among High Demand Patients

Ain Shams University20 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anterior Cruciate Ligament Tear

Interventions

Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesisPROCEDURE

Anatomical single bundle ACLR with modified Lemiere technique

Isolated anterior cruciate ligament reconstruction onlyPROCEDURE

arthroscopic anatomical single bundle ACL Reconstruction

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ahmed Abdel Salam Abdel Halim

Cairo, Abbasia, Egypt

Outcomes

Primary Outcomes

failure rate

retear of ACL graft confirmed by clinical examination and MRI

Time frame: one year follow up

Secondary Outcomes

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)

Time frame: at 3,6,9,12 months

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)

Time frame: at 3,6,9,12 months

antero-posterior instability measure

measure AP instability by KT1000 lachmeter for injured and non injured knee

Time frame: 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)

Time frame: one year follow up

Data from ClinicalTrials.gov

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