Axial Alignment in Patients Operated Using the Visionaire Patient Matched Cutting Blocks

Study Overview
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Brief Summary
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- Title: PATIENT-MATCHED INSTRUMENTATION VS. STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION Short Title: Visionaire Alignment Methodology: Monocentric, Single Blinded, Randomized Controlled Trial Study Duration: November 2010 to July 2014 Study Centres: Leicester General Hospital, United Kingdom (UK)

Detailed Description
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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 primary research objective is to evaluate the axial alignment and component position in TKA with use of Smith & Nephew's VISIONAIRE Patient Matched Technology and to compare with the alignment when standard instrumentation. Secondary research objectives include assessing the safety and effectiveness of the VISIONAIRE patient matched technology as compared to commonly accepted standard instrumentation in patients suffering from symptomatic osteoarthritis of the knee joint. - Outcome Measures: Implant alignment and Component position by means of CT-scans Knee Society Score EuroQol-5 Dimensions (EQ-5D) Knee injury and Osteoarthritis Outcome Score (KOOS) Oxford Knee Score Knee-related adverse events Standard and full leg x-ray Number of Subjects: 70 (2*35) Enrollment time: 18 months Diagnosis and Main Inclusion Criteria: Patients with osteoarthritis of the knee requiring total knee arthroplasty Study Product, Dose, Route, Regimen: VISIONAIRE patient matched technology versus the commonly accepted standard instrumentation for the Genesis II total knee arthroplasty implant

Official Title
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PATIENT-MATCHED INSTRUMENTATION Versus (vs) STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Procedure: Visionaire
* Procedure: Standard surgical technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visionaire<br>the group who will be operated by the use of Visionaire patient matched cutting blocks | Procedure: Visionaire<br>* Implantation of a Genesis II Total Knee by means of Visionaire patient matched cutting blocks.<br>* Other names: Visionaire Instruments;|
| Active Comparator: Standard Surgical technique<br>The group who will be operated by means fo standard surgical technique | Procedure: Standard surgical technique<br>* Implantation of Genesis II Total Knee system by means of standard surgical technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial Alignment | Axial alignment will be measured by means of CT scan and long leg x-ray | 6 weeks, | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical effectiveness and safety. | Safety and effectiveness will be measured by means of Knee Society Score, Oxford Score, EQ-5D and radiographic findings | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial, Total Knee Arthroplasty, Patient Matched Cutting Blocks