Medial vs Lateral Approach for Total Knee Replacement on Valgus Knee: a Randomized Clinical Trial
ValgusKnee
1 other identifier
interventional
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 16, 2013
CompletedFirst Posted
Study publicly available on registry
October 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJanuary 6, 2015
October 1, 2013
5.2 years
October 16, 2013
January 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knee Score
Evaluation of patient's pain and function using the Knee Society questionnaire
1 year
Secondary Outcomes (4)
WOMAC
2 years
VAS
2 years
Knee alignment
6 months
Hemoglobin
3 days
Study Arms (2)
Medial approach
ACTIVE COMPARATORMedial parapatellar approach (classic approach)
Keblish approach
EXPERIMENTALLateral parapatellar approach (Keblish approach)
Interventions
Total knee replacement performed through a longitudinal incision medial to the patella
Total knee replacement performed through a longitudinal incision lateral to the patella
Eligibility Criteria
You may qualify if:
- Severe osteoarthritis (Kellgren \& Lawrence grade 4)
- Valgus deformity of the knee
- Read and sign the informed consent form
You may not qualify if:
- Severe pain in other joint (VAS\>6)
- Comorbidities or any condition that contraindicate the procedure
- Previous arthroplasty on the index knee
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas da UNICAMP
Campinas, São Paulo, 13083-888, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandro R Zorzi, MsC
University of Campinas
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2013
First Posted
October 18, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
January 6, 2015
Record last verified: 2013-10