Status:
TERMINATED
Axial Alignment in Patients Operated Using the Visionaire Patient Matched Cutting Blocks
Lead Sponsor:
Smith & Nephew Orthopaedics AG
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
\- Title: PATIENT-MATCHED INSTRUMENTATION VS. STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION * Short Title: Visionaire Alignment ...
Detailed Description
Malalignment is one of the main reasons for knee arthroplasty revision. With the use of patient matched cutting block we expect better axial alignment of the components. Research Objectives: * The p...
Eligibility Criteria
Inclusion
- Indication for TKA, Axial alignment between 10 degrees valgus and 20 degrees varus, BMI \<36, patient must be amendable for both Genesis II total knee and Visioniare cutting blocks
Exclusion
- Insufficient femoral or tibia bone stock, inflammatory arthritis (e.g. rheumatoid arthritis), patient is immunosuppressed, has an active infection (local or systemic), patient has physical, emotional or neurological conditions that would compromise the patients compliance with rehabilitation and follow up.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01224522
Start Date
March 1 2011
End Date
August 1 2014
Last Update
April 14 2015
Active Locations (1)
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1
Leicester General Hospital
Leicester, United Kingdom, LE5 4PW