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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03416946

Enrollment

Registered

2018-01-31

Start date

2011-12-01

Completion date

2017-05-01

Last updated

2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Total knee replacement

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.

Interventions

DEVICEVisionaire

Custom cutting block using MRI to create patient specific instrumentations

OTHERTraditional

Traditional cutting method

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Randomization will occur after enrolment and subjects will be blinded to assignment group. All subjects will be scheduled for and receive the same MRI experience. It is not possible to blind the surgeon to the surgical technique.

Intervention model description

The block randomization process will be stratified by surgeon to ensure equal distribution between the two surgical techniques.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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).
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.
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).
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.

Other

Measure	Time frame	Description
Other Measures: Adverse Events	Peri-operative, intra-operative and post-operative	Peri-operative complications such as deep venous thrombosis, pulmonary emboli, wound complications and cardiac events. Post-operative complication such as infection, loosening, etc.
Blood Loss	Intra-operative	Blood loss during surgery \>100ml (n)
Length of Stay (LOS)	Peri-operative	Length of hospital stay
Other Measure: Time	Intra-operative	Surgical and tourniquet time

Countries

Canada

Participant flow

Participants by arm

Arm	Count
Custom Block Instrumentation Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	25
Traditional Instrumentation Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method	29
Total	54

Baseline characteristics

Characteristic	Custom Block Instrumentation	Traditional Instrumentation	Total
Age, Continuous	63.8 years STANDARD_DEVIATION 9.2	65.7 years STANDARD_DEVIATION 9.2	64.8 years STANDARD_DEVIATION 9.1
Body Mass Index	33.6 kg/m2 STANDARD_DEVIATION 7.2	32.0 kg/m2 STANDARD_DEVIATION 6	32.76 kg/m2 STANDARD_DEVIATION 6.6
Knee Left	12 Participants	17 Participants	29 Participants
Knee Right	13 Participants	12 Participants	25 Participants
Pre-op HKA angle	-5.2 degree STANDARD_DEVIATION 5.9	-6.7 degree STANDARD_DEVIATION 7.5	-6.0 degree STANDARD_DEVIATION 6.8
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment Canada	25 Participants	29 Participants	54 Participants
Sex: Female, Male Female	18 Participants	22 Participants	40 Participants
Sex: Female, Male Male	7 Participants	7 Participants	14 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 25	0 / 29
other Total, other adverse events	0 / 25	0 / 29
serious Total, serious adverse events	4 / 25	1 / 29

Outcome results

Primary

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

Arm	Measure	Value (NUMBER)
Custom Block Instrumentation	Number of HKA Angle Outliers	6 outliers
Traditional Instrumentation	Number of HKA Angle Outliers	10 outliers

Primary

Radiographic Alignment

Using 3 foot standing film

Time frame: 8 Weeks

Arm	Measure	Group	Value (MEAN)	Dispersion
Custom Block Instrumentation	Radiographic Alignment	Femoral coronal angle	89.4 degree	Standard Deviation 1.9
Custom Block Instrumentation	Radiographic Alignment	Femoral sagittal angle	87.4 degree	Standard Deviation 2.2
Custom Block Instrumentation	Radiographic Alignment	Tibial coronal angle	89.2 degree	Standard Deviation 1.5
Custom Block Instrumentation	Radiographic Alignment	Tibial sagittal angle	3.8 degree	Standard Deviation 3
Custom Block Instrumentation	Radiographic Alignment	Post-op HKA angle	-1.6 degree	Standard Deviation 3.2
Traditional Instrumentation	Radiographic Alignment	Tibial sagittal angle	7.7 degree	Standard Deviation 3.6
Traditional Instrumentation	Radiographic Alignment	Post-op HKA angle	-1.8 degree	Standard Deviation 2.7
Traditional Instrumentation	Radiographic Alignment	Femoral coronal angle	89.3 degree	Standard Deviation 2.5
Traditional Instrumentation	Radiographic Alignment	Tibial coronal angle	89.1 degree	Standard Deviation 1.6
Traditional Instrumentation	Radiographic Alignment	Femoral sagittal angle	87.3 degree	Standard Deviation 2.7

p-value: 0.79t-test, 2 sided

Secondary

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.