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

NCT ID: NCT01965886

Last Updated: 2015-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2018-12-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Medial approach

Medial parapatellar approach (classic approach)

Group Type: ACTIVE_COMPARATOR

Medial approach

Intervention Type: PROCEDURE

Total knee replacement performed through a longitudinal incision medial to the patella

Keblish approach

Lateral parapatellar approach (Keblish approach)

Group Type: EXPERIMENTAL

Keblish approach

Intervention Type: PROCEDURE

Total knee replacement performed through a longitudinal incision lateral to the patella

Interventions

Medial approach

Total knee replacement performed through a longitudinal incision medial to the patella

Intervention Type: PROCEDURE

Keblish approach

Total knee replacement performed through a longitudinal incision lateral to the patella

Intervention Type: PROCEDURE

Other Intervention Names

medial parapatellar approach; classic approach; lateral approach; lateral parapatellar approach

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campinas, Brazil

OTHER

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandro R Zorzi, MsC

Role: PRINCIPAL_INVESTIGATOR

University of Campinas

Locations

Hospital de Clínicas da UNICAMP

Campinas, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Gustavo C Campos, MD

Role: CONTACT

gustavoccampos@terra.com.br

+551983318000

Facility Contacts

Alessandro R Zorzi, MsC

Role: primary

alessandrozorzi@uol.com.br

+5519992809303

Other Identifiers

VALGUSKNEE

Identifier Type: -

Identifier Source: org_study_id