Patients With Acl Injury and Varus Knee Will Undergo Acl Reconstruction Alone, or Combined With High Tibial Osteotomy in the Same Session.

Mostafa Hassanein, Msc24 enrolled

Overview

The purpose of this study is to compare the results of single-stage anterior cruciate ligament reconstruction combined with high tibial osteotomy and anterior cruciate ligament reconstruction alone in knees with varus malalignment and anterior cruciate ligament deficiency. Evaluation will be clinically, radiologically and time needed to return to pre injury activity level. Our Hypothesis: Simultaneous anterior cruciate ligament reconstruction and high tibial osteotomy provides good functional scores, low rate of graft failure and early return to pre injury activity level with minimal added morbidity.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ACL - Anterior Cruciate Ligament Deficiency Varus Deformity of Tibia (Disorder)ACL Injury Knee Deformity

Interventions

medial opening wedge high tibial osteotomyPROCEDURE

medial opening wedge valgus high tibial osteotomy

anterior cruciate ligament reconstructionPROCEDURE

anterior cruciate ligament reconstruction

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 20 and 50. * Knee varus malalignment 7-10°. * ACL injury with clinical anterior instability confirmed by MRI. Exclusion Criteria: * Osteoarthritis (Kellgren-Lawrence grade IV). * Inflammatory joint disease. * Knee flexion \< 120° * Knee fixed flexion deformity \> 10°. * BMI \>30 * Any ligamentous or meniscal knee injury other than ACL injury.

Locations (1)

Ain Shams University Hospitals

Cairo, Egypt

Outcomes

Primary Outcomes

Lysholm knee score

knee score from 0 to 100 where a higher score means better outcome.

Time frame: 1 month post operative

Lysholm knee score

knee score from 0 to 100 where a higher score means better outcome.

Time frame: 3 month post operative

Lysholm knee score

knee score from 0 to 100 where a higher score means better outcome.

Time frame: 6 month post operative

Tegner activity level

activity level from 0 to 11 where 11 means highest level

Time frame: 1 month post operative

Tegner activity level

activity level from 0 to 11 where 11 means highest level

Time frame: 3 months post operative

Tegner activity level

activity level from 0 to 11 where 11 means highest level

Time frame: 6 months post operative

Return to pre injury level

time needed by the patient in months post operative to return to pre injury activity level

Time frame: through study completion, an average of 7 months

Secondary Outcomes

knee range of motion

measure knee range of motion in degrees "flexion and extension"

Time frame: pre operative, 1 month, 3months, and 6 months post operative

knee stability

Lachman knee stability test

Time frame: pre operative, 1 month, 3months, and 6 months post operative

Data from ClinicalTrials.gov

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