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

Orthopaedic Innovation Centre54 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

VisionaireDEVICE

Custom cutting block using MRI to create patient specific instrumentations

TraditionalOTHER

Traditional cutting method

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient is male or female ages 18 and over. 2. Patient is having primary total knee replacement 3. Patient is willing to sign the informed consent and to come for all study visits. Exclusion Criteria: 1. Deformity of the femur preventing use of the intra-medullary guide utilized in the regular instrumentation set. 2. 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. 3. 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. 4. Patients scheduled for bilateral knee surgery (simultaneous or staged)

Locations (1)

Concordia Hospital

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

Radiographic Alignment

Using 3 foot standing film

Time frame: 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.

Time frame: 8 Weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Data from ClinicalTrials.gov

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