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

Osteoarthritis Clinical Trial

— ValgusKnee  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01965886
• Other study ID #: VALGUSKNEE
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2013
• Last updated: January 5, 2015
• Start date: October 2013
• Est. completion date: December 2018

Study information

• Verified date: October 2013
• Source: University of Sao Paulo General Hospital
• Contact: Gustavo C Campos, MD
• Phone: +551983318000
• Email: gustavoccampos[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Medial approach
Total knee replacement performed through a longitudinal incision medial to the patella
• Keblish approach
Total knee replacement performed through a longitudinal incision lateral to the patella

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas da UNICAMP	Campinas	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Score	Evaluation of patient's pain and function using the Knee Society questionnaire	1 year	No
Secondary	WOMAC	Evaluation of patient's symptoms using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	2 years	No
Secondary	VAS	Evaluation of patient's symptoms using the VAS (Visual Analogic Scale of pain)	2 years	No
Secondary	Knee alignment	Radiographic analysis of the knee alignment	6 months	Yes
Secondary	Hemoglobin	Analysis of patient's hemoglobin to estimate blood loss	3 days	Yes