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

Not Applicable

Completed

Conditions: Osteoarthritis, Knee

Interventions: Device: Visionaire
Other: Traditional

Registration Number: NCT03416946

Lead Sponsor: Orthopaedic Innovation Centre

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 54

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Custom Block Instrumentation	Visionaire	Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system
Traditional Instrumentation	Traditional	Traditional cutting methods for Total Knee Replacement

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
EuroQol (EQ) Five Dimension (5D) Survey	Preoperative, 1 and 2 years	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.
Oxford Knee Score	Preoperative, 1 and 2 years	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.
Pain Catastrophizing Scale (PCS) Score	Preoperative, 1 and 2 years	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.
Hip Pain	Preoperative, 1 and 2 years	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).
Patient Satisfaction	Preoperative, 1 and 2 years	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).
University of California Los Angeles (UCLA) Activity Score	Preoperative, 1 and 2 years	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.