Trial Outcomes & Findings for Custom Cutting Block Instrument vs Regular Instrumentation Total Knee Replacement (TKR) (NCT NCT03416946)

NCT ID: NCT03416946

Last Updated: 2021-10-04

Results Overview

Using 3 foot standing film

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: 8 Weeks
• Results posted on: 2021-10-04

Participant Flow

Participant milestones

Measure	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	Traditional Instrumentation Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method
Overall Study STARTED	25	29
Overall Study COMPLETED	25	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Custom Block Instrumentation n=25 Participants Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	Traditional Instrumentation n=29 Participants Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method	Total n=54 Participants Total of all reporting groups
Age, Continuous	63.8 years STANDARD_DEVIATION 9.2 • n=25 Participants	65.7 years STANDARD_DEVIATION 9.2 • n=29 Participants	64.8 years STANDARD_DEVIATION 9.1 • n=54 Participants
Sex: Female, Male Female	18 Participants n=25 Participants	22 Participants n=29 Participants	40 Participants n=54 Participants
Sex: Female, Male Male	7 Participants n=25 Participants	7 Participants n=29 Participants	14 Participants n=54 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	25 Participants n=25 Participants	29 Participants n=29 Participants	54 Participants n=54 Participants
Body Mass Index	33.6 kg/m2 STANDARD_DEVIATION 7.2 • n=25 Participants	32.0 kg/m2 STANDARD_DEVIATION 6.0 • n=29 Participants	32.76 kg/m2 STANDARD_DEVIATION 6.6 • n=54 Participants
Knee Right	13 Participants n=25 Participants	12 Participants n=29 Participants	25 Participants n=54 Participants
Knee Left	12 Participants n=25 Participants	17 Participants n=29 Participants	29 Participants n=54 Participants
Pre-op HKA angle	-5.2 degree STANDARD_DEVIATION 5.9 • n=25 Participants	-6.7 degree STANDARD_DEVIATION 7.5 • n=29 Participants	-6.0 degree STANDARD_DEVIATION 6.8 • n=54 Participants

PRIMARY outcome

Timeframe: 8 Weeks

Using 3 foot standing film

Outcome measures

Measure	Custom Block Instrumentation n=25 Participants Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	Traditional Instrumentation n=29 Participants Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method
Radiographic Alignment Post-op HKA angle	-1.6 degree Standard Deviation 3.2	-1.8 degree Standard Deviation 2.7
Radiographic Alignment Femoral coronal angle	89.4 degree Standard Deviation 1.9	89.3 degree Standard Deviation 2.5
Radiographic Alignment Tibial coronal angle	89.2 degree Standard Deviation 1.5	89.1 degree Standard Deviation 1.6
Radiographic Alignment Femoral sagittal angle	87.4 degree Standard Deviation 2.2	87.3 degree Standard Deviation 2.7
Radiographic Alignment Tibial sagittal angle	3.8 degree Standard Deviation 3.0	7.7 degree Standard Deviation 3.6

PRIMARY outcome

Timeframe: 8 Weeks

The angle formed between the mechanical axes of the femur and tibia create the hip-knee-ankle (HKA) angle.

Outcome measures

Measure	Custom Block Instrumentation n=25 Participants Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	Traditional Instrumentation n=29 Participants Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method
Number of HKA Angle Outliers	6 outliers	10 outliers

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Custom Block Instrumentation n=25 Participants Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	Traditional Instrumentation n=29 Participants Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method
EuroQol (EQ) Five Dimension (5D) Survey Pre-op	0.760 units on a scale Standard Deviation 0.058	0.744 units on a scale Standard Deviation 0.061
EuroQol (EQ) Five Dimension (5D) Survey 1 Year	0.101 units on a scale Standard Deviation 0.090	0.110 units on a scale Standard Deviation 0.086
EuroQol (EQ) Five Dimension (5D) Survey 2 Years	0.112 units on a scale Standard Deviation 0.110	0.120 units on a scale Standard Deviation 0.098

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Custom Block Instrumentation n=25 Participants Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	Traditional Instrumentation n=29 Participants Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method
Oxford Knee Score Pre-op	22.8 units on a scale Standard Deviation 7.8	19.6 units on a scale Standard Deviation 6.8
Oxford Knee Score Improvement at 1 Year	10.7 units on a scale Standard Deviation 11.4	15.3 units on a scale Standard Deviation 7.7
Oxford Knee Score Improvement at 2 Year	13.3 units on a scale Standard Deviation 12.4	12.8 units on a scale Standard Deviation 8.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Custom Block Instrumentation n=25 Participants Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	Traditional Instrumentation n=29 Participants Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method
Pain Catastrophizing Scale (PCS) Score Pre-op	14.0 units on a scale Standard Deviation 12.3	17.4 units on a scale Standard Deviation 11.9
Pain Catastrophizing Scale (PCS) Score Improvement at 1 Year	9.1 units on a scale Standard Deviation 12.3	10.5 units on a scale Standard Deviation 14.4
Pain Catastrophizing Scale (PCS) Score Improvement at 2 Year	8.0 units on a scale Standard Deviation 13.7	6.4 units on a scale Standard Deviation 14.9

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Custom Block Instrumentation n=25 Participants Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	Traditional Instrumentation n=29 Participants Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method
Hip Pain Pre-op	61.6 units on a scale Standard Deviation 23.4	67.4 units on a scale Standard Deviation 20.6
Hip Pain Improvement at 1 Year	-38.4 units on a scale Standard Deviation 34.4	-40.1 units on a scale Standard Deviation 32.9
Hip Pain Improvement at 2 Year	-40.8 units on a scale Standard Deviation 40.1	-46.3 units on a scale Standard Deviation 24.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Custom Block Instrumentation n=25 Participants Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	Traditional Instrumentation n=29 Participants Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method
University of California Los Angeles (UCLA) Activity Score Pre-op	4.4 units on a scale Standard Deviation 1.8	3.4 units on a scale Standard Deviation 1.1
University of California Los Angeles (UCLA) Activity Score Improvement at 1 Year	0.8 units on a scale Standard Deviation 1.92	1.6 units on a scale Standard Deviation 1.6
University of California Los Angeles (UCLA) Activity Score Improvement at 2 Year	1.0 units on a scale Standard Deviation 2.0	1.6 units on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Custom Block Instrumentation n=25 Participants Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	Traditional Instrumentation n=29 Participants Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method
Patient Satisfaction Pre-op	23.0 units on a scale Standard Deviation 23.5	25.6 units on a scale Standard Deviation 26.2
Patient Satisfaction Improvement at 1 Year	59.1 units on a scale Standard Deviation 31.6	57.4 units on a scale Standard Deviation 28.5
Patient Satisfaction Improvement at 2 Year	62.0 units on a scale Standard Deviation 31.3	56.0 units on a scale Standard Deviation 29.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Intra-operative

Surgical and tourniquet time

Outcome measures

Measure	Custom Block Instrumentation n=25 Participants Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	Traditional Instrumentation n=29 Participants Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method
Other Measure: Time	64.2 Minutes Standard Deviation 16.5	57 Minutes Standard Deviation 14

OTHER_PRE_SPECIFIED outcome

Timeframe: Intra-operative

Blood loss during surgery >100ml (n)

Outcome measures

Measure	Custom Block Instrumentation n=25 Participants Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	Traditional Instrumentation n=29 Participants Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method
Blood Loss	5 Participants	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Peri-operative

Length of hospital stay

Outcome measures

Measure	Custom Block Instrumentation n=25 Participants Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	Traditional Instrumentation n=29 Participants Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method
Length of Stay (LOS)	4.0 Days Standard Deviation 1.5	4.2 Days Standard Deviation 2.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Custom Block Instrumentation n=25 Participants Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	Traditional Instrumentation n=29 Participants Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method
Other Measures: Adverse Events	4 participants	1 participants

Adverse Events

Custom Block Instrumentation

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Instrumentation

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Custom Block Instrumentation n=25 participants at risk Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations	Traditional Instrumentation n=29 participants at risk Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method
Infections and infestations Revision	8.0% 2/25 • Number of events 2 • 2 Years	0.00% 0/29 • 2 Years
Surgical and medical procedures Revision	4.0% 1/25 • Number of events 1 • 2 Years	0.00% 0/29 • 2 Years
Surgical and medical procedures Manipulation	4.0% 1/25 • Number of events 1 • 2 Years	0.00% 0/29 • 2 Years

Other adverse events

Adverse event data not reported

Additional Information

Trevor Gascoyne

Orthopaedic Innovation Centre

Phone: 204-926-1235

Email: tgascoyne@orthoinno.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place