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

Not Applicable

• Conditions: Osteoarthritis
• Interventions: Procedure: Keblish approach; Procedure: Medial approach

• Registration Number: NCT01965886
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2013-10
• Study Start: 2013-10
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-10-16
• Study First Posted: 2013-10-18
• Last Update Submitted: 2015-01-05
• Last Update Posted: 2015-01-06
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Keblish approach	Keblish approach	Lateral parapatellar approach (Keblish approach)
Medial approach	Medial approach	Medial parapatellar approach (classic approach)

Primary Outcome Measures

Name	Time	Method
Knee Score	1 year	Evaluation of patient's pain and function using the Knee Society questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital de Clínicas da UNICAMP; 🇧🇷 Campinas, SP, Brazil