Custom Cutting Block Instrument vs Regular Instrumentation Total Knee Replacement (TKR)

Study Overview
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Brief Summary
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To determine if the use of patient-specific custom cutting blocks for implantation of total knee components results in improved limb alignment and component positioning compared to regular instrumentation.

Detailed Description
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This is a randomized controlled trial. Patients will be randomized to have their knee implanted using either the patient-specific custom cutting blocks or the regular instrumentation system. Functional and radiographic outcomes will be assessed in a blinded fashion. The Smith and Nephew Legion Primary® total knee system will be used in both groups; this is an implant with a good long term track record based on the Genesis II design. All surgeons have used and are familiar with the regular instrumentation. They will be instructed in the use of the patient-specific custom cutting blocks prior to study initiation.

Official Title
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A Double-blinded, Randomized, Controlled Trial of Total Knee Replacement Using Custom Cutting Block Instrument vs Regular Instrumentation

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Visionaire
* Other: Traditional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is male or female ages 18 and over. Patient is having primary total knee replacement Patient is willing to sign the informed consent and to come for all study visits. Exclusion Criteria: Deformity of the femur preventing use of the intra-medullary guide utilized in the regular instrumentation set. Necessity for the use of constrained implants. These types of implants have intra-medullary stems, therefore all bone cuts need to be referenced off intramedullary guides, making image guided bone cuts inappropriate. Patients undergoing knee replacement revision surgery. Theses types of implants also have stems, making the use of image guided bone cuts inappropriate for the same reasons. Patients scheduled for bilateral knee surgery (simultaneous or staged)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: The block randomization process will be stratified by surgeon to ensure equal distribution between the two surgical techniques.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Custom Block Instrumentation<br>Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system | Device: Visionaire<br>* Custom cutting block using MRI to create patient specific instrumentations<br>|
| Active Comparator: Traditional Instrumentation<br>Traditional cutting methods for Total Knee Replacement | Other: Traditional<br>* Traditional cutting method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Alignment | Using 3 foot standing film | 8 Weeks | 
| Number of HKA Angle Outliers | The angle formed between the mechanical axes of the femur and tibia create the hip-knee-ankle (HKA) angle. | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQol (EQ) Five Dimension (5D) Survey | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the EQ-5D (patient reported). The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, this health state is range from 0 to 1.0. Higher scores indicate improved quality of life within each dimension. | Preoperative, 1 and 2 years | 
| Oxford Knee Score | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Oxford 12 scores (patient reported). The score ranges from 0 to 48 with higher scores indicating improved function and less pain. | Preoperative, 1 and 2 years | 
| Pain Catastrophizing Scale (PCS) Score | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the PCS (patient reported). The total score ranges from 0 to 52 with higher scores indicating greater pain catastrophizing. Sub-scales will not be used in this study. | Preoperative, 1 and 2 years | 
| Hip Pain | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Pain Visual Analog Scale (VAS). The scale is from 0 to 100, 0=no pain and at 100= worst pain. (patient reported). | Preoperative, 1 and 2 years | 
| University of California Los Angeles (UCLA) Activity Score | Evaluate change from preoperative baseline to 1 and 2 year post operative in activity level assessments using the UCLA Activity score (patient reported). The scale ranges from 1-10 with higher values associated with more intense activities. | Preoperative, 1 and 2 years | 
| Patient Satisfaction | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Satisfaction Visual Analog Scale (VAS). The scale is from 0 to 100, 0=Not Satisfied and at 100=Satisfied. (patient reported). | Preoperative, 1 and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee replacement