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

Primary Purpose

Osteoarthritis

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Medial approach

Keblish approach

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring osteoarthritis, knee, arthroplasty, replacement

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital de Clínicas da UNICAMPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Medial approach

Keblish approach

Arm Description

Medial parapatellar approach (classic approach)

Lateral parapatellar approach (Keblish approach)

Outcomes

Primary Outcome Measures

Knee Score

Evaluation of patient's pain and function using the Knee Society questionnaire

Secondary Outcome Measures

WOMAC

Evaluation of patient's symptoms using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

VAS

Evaluation of patient's symptoms using the VAS (Visual Analogic Scale of pain)

Knee alignment

Radiographic analysis of the knee alignment

Hemoglobin

Analysis of patient's hemoglobin to estimate blood loss

Full Information

NCT ID

NCT01965886

First Posted

October 16, 2013

Last Updated

January 5, 2015

Sponsor

University of Sao Paulo General Hospital

Collaborators

University of Campinas, Brazil

1. Study Identification

Unique Protocol Identification Number

NCT01965886

Brief Title

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

Acronym

ValgusKnee

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Sao Paulo General Hospital

Collaborators

University of Campinas, Brazil

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

osteoarthritis, knee, arthroplasty, replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Medial approach

Arm Type

Active Comparator

Arm Description

Medial parapatellar approach (classic approach)

Arm Title

Keblish approach

Arm Type

Experimental

Arm Description

Lateral parapatellar approach (Keblish approach)

Intervention Type

Procedure

Intervention Name(s)

Medial approach

Other Intervention Name(s)

medial parapatellar approach, classic approach

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Keblish approach

Other Intervention Name(s)

lateral approach, lateral parapatellar approach

Intervention Description

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

Primary Outcome Measure Information:

Title

Knee Score

Description

Evaluation of patient's pain and function using the Knee Society questionnaire

Time Frame

1 year

Secondary Outcome Measure Information:

Title

WOMAC

Description

Evaluation of patient's symptoms using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Time Frame

2 years

Title

VAS

Description

Evaluation of patient's symptoms using the VAS (Visual Analogic Scale of pain)

Time Frame

2 years

Title

Knee alignment

Description

Radiographic analysis of the knee alignment

Time Frame

6 months

Title

Hemoglobin

Description

Analysis of patient's hemoglobin to estimate blood loss

Time Frame

3 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gustavo C Campos, MD

Phone

+551983318000

gustavoccampos@terra.com.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alessandro R Zorzi, MsC

Organizational Affiliation

University of Campinas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Clínicas da UNICAMP

City

Campinas

State/Province

ZIP/Postal Code

13083-888

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alessandro R Zorzi, MsC

Phone

+5519992809303

alessandrozorzi@uol.com.br

First Name & Middle Initial & Last Name & Degree

Alessandro R Zorzi, MsC

First Name & Middle Initial & Last Name & Degree

Gustavo C Campos, MD

12. IPD Sharing Statement

Learn more about this trial

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

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