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

Study Overview
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Brief Summary
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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.

Official Title
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Outcomes of Anterior Cruciate Ligament Reconstruction With and Without High Tibial Osteotomy in Knees With Varus Malalignment. Comparative Study

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

Intervention / Treatment
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* Procedure: medial opening wedge high tibial osteotomy
* Procedure: anterior cruciate ligament reconstruction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 12 patients with varus knee malalignment and acl deficiency under went acl reconstruction and hto<br>anterior cruciate ligament reconstruction and medial opening wedge high tibial osteotomy in the same session | Procedure: medial opening wedge high tibial osteotomy<br>* medial opening wedge valgus high tibial osteotomy<br>Procedure: anterior cruciate ligament reconstruction<br>* anterior cruciate ligament reconstruction<br>|
| Active Comparator: 12 patients with varus knee malalignment and acl deficiency underwent acl reconstruction<br>anterior cruciate ligament reconstruction alone. | Procedure: anterior cruciate ligament reconstruction<br>* anterior cruciate ligament reconstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysholm knee score | knee score from 0 to 100 where a higher score means better outcome. | 1 month post operative | 
| Lysholm knee score | knee score from 0 to 100 where a higher score means better outcome. | 3 month post operative | 
| Lysholm knee score | knee score from 0 to 100 where a higher score means better outcome. | 6 month post operative | 
| Tegner activity level | activity level from 0 to 11 where 11 means highest level | 1 month post operative | 
| Tegner activity level | activity level from 0 to 11 where 11 means highest level | 3 months post operative | 
| Tegner activity level | activity level from 0 to 11 where 11 means highest level | 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 | through study completion, an average of 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knee range of motion | measure knee range of motion in degrees flexion and extension | pre operative, 1 month, 3months, and 6 months post operative | 
| knee stability | Lachman knee stability test | pre operative, 1 month, 3months, and 6 months post operative |