OsteoarthritisValgusKneeNCT01965886
Medial vs Lateral Approach for Total Knee Replacement on Valgus Knee: a Randomized Clinical Trial
A study testing Medial approach and Keblish approach in people with Osteoarthritis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Medial approach and Keblish approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2013to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Severe osteoarthritis (Kellgren \& Lawrence grade 4)
- Valgus deformity of the knee
- Read and sign the informed consent form
Who cannot join
- Severe pain in other joint (VAS>6)
- Comorbidities or any condition that contraindicate the procedure
- Previous arthroplasty on the index knee
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas da UNICAMP
Campinas, São Paulo, 13083-888
Alessandro R Zorzi, MsC, +5519992809303, alessandrozorzi@uol.com.br
Alessandro R Zorzi, MsC
About this study
Official title: 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.
Read the 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
- Being tested
- Medial approach, Keblish approach
- Keywords
- osteoarthritis, knee, arthroplasty, replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial approachProcedure or surgery
Also called medial parapatellar approach, classic approach
Total knee replacement performed through a longitudinal incision medial to the patella
Keblish approachProcedure or surgery
Also called lateral approach, lateral parapatellar approach
Total knee replacement performed through a longitudinal incision lateral to the patella
| Study group | Role | What they receive |
|---|---|---|
| Medial approach | Active comparator | Medial parapatellar approach (classic approach) Receives: Procedure: Medial approach |
| Keblish approach | Experimental | Lateral parapatellar approach (Keblish approach) Receives: Procedure: Keblish approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Score
Evaluation of patient's pain and function using the Knee Society questionnaire
Measured: 1 year
Secondary outcomes (4)
WOMAC
Evaluation of patient's symptoms using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: 2 years
VAS
Evaluation of patient's symptoms using the VAS (Visual Analogic Scale of pain)
Measured: 2 years
Knee alignment
Radiographic analysis of the knee alignment
Measured: 6 months
Hemoglobin
Analysis of patient's hemoglobin to estimate blood loss
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil
- Responsible party
- Sponsor
- Investigators
- Alessandro R Zorzi, MsC, Principal investigator, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965886
- Sponsor's protocol ID
- VALGUSKNEE
- Acronym
- ValgusKnee
- Status last verified
- Oct 2013
- First submitted
- 16 Oct 2013
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial vs Lateral Approach for Total Knee Replacement on Valgus Knee: Prospective and Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01965886
- Acronym / sponsor ID
- ValgusKnee / VALGUSKNEE
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, knee, arthroplasty, replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil
- Study start
- Oct 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medial approach | Active comparator | Procedure: Medial approachMedial parapatellar approach (classic approach) |
| Keblish approach | Experimental | Procedure: Keblish approachLateral parapatellar approach (Keblish approach) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Severe osteoarthritis (Kellgren \& Lawrence grade 4)
- Valgus deformity of the knee
- Read and sign the informed consent form
Key exclusion criteria (3 listed)
- Severe pain in other joint (VAS>6)
- Comorbidities or any condition that contraindicate the procedure
- Previous arthroplasty on the index knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medial approachAlso: medial parapatellar approach, classic approachTotal knee replacement performed through a longitudinal incision medial to the patella | Procedure or surgery | Medial approach |
| Keblish approachAlso: lateral approach, lateral parapatellar approachTotal knee replacement performed through a longitudinal incision lateral to the patella | Procedure or surgery | Keblish approach |
Primary outcome
Knee Score
Time frame: 1 year
Evaluation of patient's pain and function using the Knee Society questionnaire
4 secondary outcomes
WOMAC
Time frame: 2 years
VAS
Time frame: 2 years
Knee alignment
Time frame: 6 months
Hemoglobin
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
Related trials for Osteoarthritis
Recruiting
Effect of Anti-inflammatory (ITIS) Diet in Knee Osteoarthritis
Osteoarthritis, Knee
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Active, not recruiting
Balneotherapy in Hand Osteoarthritis
Hand Osteoarthritis
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro R Zorzi, MsC principal investigator
University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medial approach and Keblish approach in people with Osteoarthritis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gustavo C Campos, MD (+551983318000, gustavoccampos@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015; AzTrials last refreshed its copy on 6 Nov 2026.