Medial vs Lateral Approach for Total Knee Replacement on Valgus Knee: a Randomized Clinical Trial

Study Overview
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Brief Summary
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The most common surgical approach to perform a total knee replacement is called medial parapatellar approach. It's effective and can be applied virtually to all types of knee deformities. The Keblish approach is an alternative approach which uses the lateral side of the patella to enter the joint. Some orthopaedic surgeons consider the latter approach a better option when facing a valgus deformity of the osteoarthritic knee but there is no convincing evidence on the literature supporting one or another approach. The objective of this study is to compare the medial vs lateral approach for total knee replacement on valgus knee.

Detailed Description
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Total knee replacement is a procedure for the treatment of advanced knee osteoarthritis. The most common surgical approach to perform a total knee replacement is called medial parapatellar approach, or simply medial approach. It's effective and can be applied virtually to all types of knee deformities. The Keblish approach is an alternative approach which uses the lateral side of the patella to enter the joint. It's also called lateral parapatellar approach. Some orthopaedic surgeons consider the latter approach a better option when facing a valgus deformity of the osteoarthritic knee. Theoretically, the Keblish approach can promote better soft tissue balance and patellar tracking, but there is no convincing evidence on the literature supporting one or another approach for a total knee replacement on valgus knee. The objective of this prospective and randomized clinical trial is to compare the medial vs lateral approach for total knee replacement on valgus knee.

Official Title
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Medial vs Lateral Approach for Total Knee Replacement on Valgus Knee: Prospective and Randomized Clinical Trial

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Medial approach
* Procedure: Keblish approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe osteoarthritis (Kellgren & Lawrence grade 4) Valgus deformity of the knee Read and sign the informed consent form Exclusion Criteria: Severe pain in other joint (VAS>6) Comorbidities or any condition that contraindicate the procedure Previous arthroplasty on the index knee
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medial approach<br>Medial parapatellar approach (classic approach) | Procedure: Medial approach<br>* Total knee replacement performed through a longitudinal incision medial to the patella<br>* Other names: classic approach;|
| Experimental: Keblish approach<br>Lateral parapatellar approach (Keblish approach) | Procedure: Keblish approach<br>* Total knee replacement performed through a longitudinal incision lateral to the patella<br>* Other names: lateral parapatellar approach;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Score | Evaluation of patient's pain and function using the Knee Society questionnaire | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC | Evaluation of patient's symptoms using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 2 years | 
| VAS | Evaluation of patient's symptoms using the VAS (Visual Analogic Scale of pain) | 2 years | 
| Knee alignment | Radiographic analysis of the knee alignment | 6 months | 
| Hemoglobin | Analysis of patient's hemoglobin to estimate blood loss | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, knee, arthroplasty, replacement