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

January 5, 2015 updated by: University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • Campinas, SP, Brazil, 13083-888
        • Recruiting
        • Hospital de Clinicas da UNICAMP
        • Contact:
        • Principal Investigator:
          • Alessandro R Zorzi, MsC
        • Sub-Investigator:
          • Gustavo C Campos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Medial approach
Medial parapatellar approach (classic approach)
Procedure: Medial approach
Total knee replacement performed through a longitudinal incision medial to the patella
Other Names:
  • medial parapatellar approach
  • classic approach
Experimental: Keblish approach
Lateral parapatellar approach (Keblish approach)
Procedure: Keblish approach
Total knee replacement performed through a longitudinal incision lateral to the patella
Other Names:
  • lateral approach
  • lateral parapatellar approach

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

University of Campinas, Brazil

Investigators

  • Principal Investigator: Alessandro R Zorzi, MsC, University of Campinas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

October 16, 2013

First Posted (Estimate)

October 18, 2013

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 5, 2015

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VALGUSKNEE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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