Trial Outcomes & Findings for Sigma CR150 Versus Sigma CR Knee RCT (NCT NCT01418378)

NCT ID: NCT01418378

Last Updated: 2019-08-28

Results Overview

The Kaplan-Meier success rate at 24-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no components revised for any reason) was censored at the time of last follow-up.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 191 participants
• Primary outcome timeframe: 2 Years
• Results posted on: 2019-08-28

Participant Flow

191 subjects were recruited at sites in the UK, India and Singapore. Enrollment took place between 3 August 2011 and 21 January 2014

After written informed consent was obtained from subjects, eligibility was confirmed and subjects were allocated a subject identification number

Participant milestones

Measure	Sigma CR 150 Subjects who received a Sigma CR 150 implant	Sigma CR Subjects who received a Sigma CR implant
Overall Study STARTED	90	88
Overall Study Subjects Who Received Study Implant	90	88
Overall Study COMPLETED	89	83
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Measure	Sigma CR 150 Subjects who received a Sigma CR 150 implant	Sigma CR Subjects who received a Sigma CR implant
Overall Study Death	1	2
Overall Study Physician Decision	0	1
Overall Study ligament imbalance	0	1
Overall Study developed chronic myopathy	0	1

Baseline Characteristics

Sigma CR150 Versus Sigma CR Knee RCT

Baseline characteristics by cohort

Measure	Sigma CR 150 n=90 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=88 Participants Subjects who received a Sigma CR implant	Total n=178 Participants Total of all reporting groups
Age, Continuous	63.2 Years STANDARD_DEVIATION 6.9 • n=5 Participants	64.4 Years STANDARD_DEVIATION 6.2 • n=7 Participants	63.8 Years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	50 Participants n=7 Participants	111 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	38 Participants n=7 Participants	67 Participants n=5 Participants
Pre-operative flexion angle	110.8 Degrees STANDARD_DEVIATION 21.4 • n=5 Participants	110.4 Degrees STANDARD_DEVIATION 19.4 • n=7 Participants	110.6 Degrees STANDARD_DEVIATION 20.4 • n=5 Participants
BMI	27.1 kg/m^2 STANDARD_DEVIATION 3.6 • n=5 Participants	27.7 kg/m^2 STANDARD_DEVIATION 3.9 • n=7 Participants	27.4 kg/m^2 STANDARD_DEVIATION 3.8 • n=5 Participants
Primary Diagnosis	90 Participants n=5 Participants	88 Participants n=7 Participants	178 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 Years

Population: Safety population

The Kaplan-Meier success rate at 24-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no components revised for any reason) was censored at the time of last follow-up.

Outcome measures

Measure	Sigma CR 150 n=90 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=88 Participants Subjects who received a Sigma CR implant
Percentage of Knees Who Survived at 2 Years Post-operative	100 Percentage of Knees remaining Interval 100.0 to 100.0	100 Percentage of Knees remaining Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: Pre-operative baseline to 2 years

Population: Per protocol population

Comparative evaluation of the change from baseline values in 2 year goniometer-measured passive flexion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg

Outcome measures

Measure	Sigma CR 150 n=73 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=63 Participants Subjects who received a Sigma CR implant
Change From Baseline in Goniometer Measured Maximum Passive Flexion at 2 Years	-3.37 degrees Standard Deviation 12.97	-0.67 degrees Standard Deviation 11.81

SECONDARY outcome

Timeframe: Pre-operative baseline to 1 year

Population: Subjects within per protocol population with complete, available data

Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Pain Subscore

The subscore ranges from 0 (no pain) to 36 (extreme pain). The subscore is then transformed into a 0 (extreme pain) to 100 (no pain) scale.

100 - (score x 100) / 36 = transformed score

Outcome measures

Measure	Sigma CR 150 n=75 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=61 Participants Subjects who received a Sigma CR implant
Knee Injury and Osteoarthritis Outcome Pain Subscore - 1 Year	46.59 Scores on a scale Standard Deviation 16.68	48.54 Scores on a scale Standard Deviation 16.69

SECONDARY outcome

Timeframe: 2 years

Population: Study subjects at 2 years - Subjects within per protocol population with complete, available data

Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Pain Subscore

The subscore ranges from 0 (no pain) to 36 (extreme pain). The subscore is then transformed into a 0 (extreme pain) to 100 (no pain) scale.

100 - (score x 100) / 36 = transformed score

Outcome measures

Measure	Sigma CR 150 n=72 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=62 Participants Subjects who received a Sigma CR implant
Knee Injury and Osteoarthritis Outcome Pain Subscore - 2 Years	51.50 Scores on a scale Standard Deviation 17.71	55.38 Scores on a scale Standard Deviation 15.40

SECONDARY outcome

Timeframe: 1 years

Population: Study subjects at 1 year - Subjects within per protocol population with complete, available data

Comparative evaluation of the change from baseline values at 1 year in Knee Injury and Osteoarthritis Outcome Symptom Subscore

The subscore ranges from 0 (no symptoms) to 36 (always have symptoms). The subscore is then transformed into a 0 (always have symptoms) to 100 (never have symptoms) scale.

100 - (score x 100) / 36 = transformed score

Outcome measures

Measure	Sigma CR 150 n=75 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=61 Participants Subjects who received a Sigma CR implant
Knee Injury and Osteoarthritis Outcome Symptoms Subscore - 1 Years	44.00 Scores on a scale Standard Deviation 20.95	39.99 Scores on a scale Standard Deviation 20.86

SECONDARY outcome

Timeframe: 2 years

Population: Study subjects at 2 year -Subjects within per protocol population with complete, available data

Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Symptom Subscore

The subscore ranges from 0 (never have symptoms) to 28 (always have symptoms). The subscore is then transformed into a 0 (always have symptoms) to 100 (never have symptoms) scale.

100 - (score x 100) / 28 = transformed score

Outcome measures

Measure	Sigma CR 150 n=72 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=63 Participants Subjects who received a Sigma CR implant
Knee Injury and Osteoarthritis Outcome Symptom Subscore - 2 Years	38.59 Scores on a scale Standard Deviation 20.33	40.65 Scores on a scale Standard Deviation 18.17

SECONDARY outcome

Timeframe: 1 year

Population: Study subjects at 1 year - Subjects within per protocol population with complete, available data

Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Symptom Subscore

The subscore ranges from 0 (no difficulty) to 68 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.

100 - (score x 100) / 68 = transformed score

Outcome measures

Measure	Sigma CR 150 n=75 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=61 Participants Subjects who received a Sigma CR implant
Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 1 Years	44.00 Scores on a scale Standard Deviation 20.95	39.99 Scores on a scale Standard Deviation 20.86

SECONDARY outcome

Timeframe: 2 year

Population: Study subjects at 2 years - Subjects within per protocol population with complete, available data

Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore

The subscore ranges from 0 (no difficulty) to 68 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.

100 - (score x 100) / 68 = transformed score

Outcome measures

Measure	Sigma CR 150 n=72 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=63 Participants Subjects who received a Sigma CR implant
Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 2 Years	38.59 Scores on a scale Standard Deviation 20.33	40.65 Scores on a scale Standard Deviation 18.17

SECONDARY outcome

Timeframe: 1 year

Population: Study subjects at 1 years - Subjects within per protocol population with complete, available data

Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore

The subscore ranges from 0 (no difficulty) to 20 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.

100 - (score x 100) / 20 = transformed score

Outcome measures

Measure	Sigma CR 150 n=73 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=60 Participants Subjects who received a Sigma CR implant
Knee Injury and Osteoarthritis Outcome - Sport and Recreation Subscore - 1 Years	46.99 Scores on a scale Standard Deviation 32.82	46.42 Scores on a scale Standard Deviation 28.91

SECONDARY outcome

Timeframe: 2 year

Population: Study subjects at 2 years - Subjects within per protocol population with complete, available data

Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore

The subscore ranges from 0 (no difficulty) to 20 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.

100 - (score x 100) / 20 = transformed score

Outcome measures

Measure	Sigma CR 150 n=70 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=63 Participants Subjects who received a Sigma CR implant
Knee Injury and Osteoarthritis Outcome Sport and Recreation Subscore - 2 Years	61.29 Scores on a scale Standard Deviation 35.60	60.40 Scores on a scale Standard Deviation 32.75

SECONDARY outcome

Timeframe: 1 year

Population: Study subjects at 1 years - Subjects within per protocol population with complete, available data

Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Activities of Quality of life Subscore

The subscore ranges from 0 (no difficulty) to 16 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.

100 - (score x 100) / 16 = transformed score

Outcome measures

Measure	Sigma CR 150 n=75 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=61 Participants Subjects who received a Sigma CR implant
Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 1 Years	50.75 Scores on a scale Standard Deviation 24.83	49.59 Scores on a scale Standard Deviation 18.71

SECONDARY outcome

Timeframe: 2 years

Population: Study subjects at 2 years - Subjects within per protocol population with complete, available data

Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Quality of Life Subscore

The subscore ranges from 0 (no difficulty) to 16 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.

100 - (score x 100) / 16 = transformed score

Outcome measures

Measure	Sigma CR 150 n=72 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=63 Participants Subjects who received a Sigma CR implant
Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 2 Years	60.33 Scores on a scale Standard Deviation 23.90	59.92 Scores on a scale Standard Deviation 21.23

SECONDARY outcome

Timeframe: 1 year

Population: Subjects at 1-year within per protocol population with complete, available data

Comparative evaluation of the change from baseline values in 1 year goniometer-measured passive Flexion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive flexion involves moving the leg through range of motion without active muscle contraction

Outcome measures

Measure	Sigma CR 150 n=74 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=62 Participants Subjects who received a Sigma CR implant
Change From Baseline in Goniometer Measured Maximum Passive Flexion at 1 Year.	-1.03 degrees Standard Deviation 12.65	-0.23 degrees Standard Deviation 12.21

SECONDARY outcome

Timeframe: 1 year

Population: Subjects at one year within per protocol population with complete, available data

Comparative evaluation of the change from baseline values in 1 year goniometer-measured passive extension. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive extension involves the leg being moved without active muscle contraction

Outcome measures

Measure	Sigma CR 150 n=74 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=62 Participants Subjects who received a Sigma CR implant
Change From Baseline in Goniometer Measured Maximum Passive Extension at 1 Year	-2.34 degrees Standard Deviation 4.84	-3.15 degrees Standard Deviation 6.89

SECONDARY outcome

Timeframe: 2 year

Population: Subjects at 2 years within per protocol population with complete, available data

Comparative evaluation of the change from baseline values in 2 year goniometer-measured passive extension. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive extension involves moving the leg without active muscle contraction

Outcome measures

Measure	Sigma CR 150 n=73 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=63 Participants Subjects who received a Sigma CR implant
Change From Baseline in Goniometer Measured Maximum Passive Extension at 2 Years	-2.63 degrees Standard Deviation 5.14	-3.44 degrees Standard Deviation 7.78

SECONDARY outcome

Timeframe: 1 year

Population: Subjects at 1 year within per protocol population with complete, available data

Comparative evaluation of the change from baseline values in 1 year goniometer-measured total range of motion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Total range of motion is the full distance the lower leg travels in relation to the upper leg.

Outcome measures

Measure	Sigma CR 150 n=74 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=62 Participants Subjects who received a Sigma CR implant
Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 1 Year	1.31 degrees Standard Deviation 13.83	2.92 degrees Standard Deviation 14.59

SECONDARY outcome

Timeframe: 2 years

Population: Subjects at 2 years within per protocol population with complete, available data

Comparative evaluation of the change from baseline values in 2 year goniometer-measured total range of motion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Total range of motion is the full distance the lower leg travels in relation to the upper leg.

Outcome measures

Measure	Sigma CR 150 n=73 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=63 Participants Subjects who received a Sigma CR implant
Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 2 Years.	-0.74 degrees Standard Deviation 14.42	2.78 degrees Standard Deviation 15.99

SECONDARY outcome

Timeframe: 1 years

Population: Subjects at 1 year within per protocol population with complete, available data

Summary of flexion contracture at 1 year time point. Flexion contracture is a shortening of the muscles that prevents the leg from fully extending

Outcome measures

Measure	Sigma CR 150 n=75 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=62 Participants Subjects who received a Sigma CR implant
Number of Participants With Flexion Contracture at 1 Year 5-10 degrees	7 Participants	5 Participants
Number of Participants With Flexion Contracture at 1 Year 11-15 degrees	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Subjects at 2 years within per protocol population with complete, available data

Summary of flexion contracture at 2 year time point.Flexion contracture is a shortening of the muscles that prevents the leg from fully extending

Outcome measures

Measure	Sigma CR 150 n=77 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=65 Participants Subjects who received a Sigma CR implant
Number of Participants With Flexion Contracture at 2 Years 11-15 degrees	0 Participants	0 Participants
Number of Participants With Flexion Contracture at 2 Years 5-10 degrees	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Subjects at 1 year within per protocol population with complete, available data

Total Knee Society Knee Score change from baseline at 1 year

The Total Knee Society Score is comprised of two scores: the Knee Score and the Function Score. Both have a 0-100 range. Sub-scales are combined to compute a total score of 100

The Total Knee Society Score is made up of pain, range of motion, alignment and stability subscores. An Excellent score is 80-100, a good score is 70-79, a fair score is 60-69 and a poor score is anything below 60.

Outcome measures

Measure	Sigma CR 150 n=74 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=62 Participants Subjects who received a Sigma CR implant
Total Knee Society Score at 1 Year	45.07 Scores on a scale Standard Deviation 17.99	52.50 Scores on a scale Standard Deviation 14.76

SECONDARY outcome

Timeframe: 2 years

Population: Subjects at 2 years within per protocol population with complete, available data

Total Knee Society Knee Score change from baseline at 2 years

The Total Knee Society Score is comprised of two scores: the Knee Score and the Function Score. Both have a 0-100 range. Sub-scales are combined to compute a total score of 100

The Total Knee Society Score is made up of pain, range of motion, alignment and stability subscores. An Excellent score is 80-100, a good score is 70-79, a fair score is 60-69 and a poor score is anything below 60.

Outcome measures

Measure	Sigma CR 150 n=73 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=63 Participants Subjects who received a Sigma CR implant
Total Knee Society Knee Score at 2 Years	46.44 Scores on a scale Standard Deviation 17.74	54.51 Scores on a scale Standard Deviation 15.71

SECONDARY outcome

Timeframe: 1 year time point

Population: Subjects at 1 year within safety population with complete, available data

Anatomic angle measured at 1 year time point.

If one draws a line from the center of the hip joint to the center of the ankle joint this is considered to be the mechanical axis of the femur.

A line drawn through the center of the femoral shaft is the anatomic axis.

The angle created at the intersection of these lines is referred to as the anatomic alignment angle.

A normal angle is approximately 7-9 degrees "valgus" or slightly "knock-kneed". "Varus" angles are less common and are also referred to as "bow-legged".

Outcome measures

Measure	Sigma CR 150 n=67 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=67 Participants Subjects who received a Sigma CR implant
Anatomic Alignment Angle Varus	1 Participants	0 Participants
Anatomic Alignment Angle valgus	66 Participants	67 Participants

SECONDARY outcome

Timeframe: 2 year time point

Population: Subjects at 2 years within safety population with complete, available data

Anatomic angle measured at 2 year time point.

If one draws a line from the center of the hip joint to the center of the ankle joint this is considered to be the mechanical axis of the femur.

A line drawn through the center of the femoral shaft is the anatomic axis.

The angle created at the intersection of these lines is referred to as the anatomic alignment angle.

A normal angle is approximately 7-9 degrees "valgus" or slightly "knock-kneed". "Varus" angles are less common and are also referred to as "bow-legged".

Outcome measures

Measure	Sigma CR 150 n=69 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=65 Participants Subjects who received a Sigma CR implant
Anatomic Alignment Angle Varus	3 Participants	0 Participants
Anatomic Alignment Angle Valgus	66 Participants	65 Participants

SECONDARY outcome

Timeframe: 1 year time point

Population: Subjects at 1 year within safety population with complete, available data

Femoral component angle measured at 1 year time point. This angle is measured between a line drawn from the center of the femoral head and a line across the bottom of the femoral implant (condyles).

Outcome measures

Measure	Sigma CR 150 n=82 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=79 Participants Subjects who received a Sigma CR implant
Alignment - Femoral Component to Anatomic Angle.	94.37 Degrees Standard Deviation 1.95	94.21 Degrees Standard Deviation 2.64

SECONDARY outcome

Timeframe: 2 year time point

Population: Subjects at 2 year within safety population with complete, available data

Femoral component angle measured at 2 year time point. This angle is measured between a line drawn from the center of the femoral head and a line across the bottom of the femoral implant (condyles).

Outcome measures

Measure	Sigma CR 150 n=80 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=77 Participants Subjects who received a Sigma CR implant
Alignment - Femoral Component to Anatomic Angle	93.94 Degrees Standard Deviation 2.11	94.48 Degrees Standard Deviation 2.2

SECONDARY outcome

Timeframe: 1 year time point

Population: Subjects at 1 year within safety population with complete, available data

Tibial component angle measured at 1 year time point. This angle is measured between a line drawn from the center of the femoral head tibial implant.

Outcome measures

Measure	Sigma CR 150 n=82 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=80 Participants Subjects who received a Sigma CR implant
Alignment - Tibial Component to Anatomic Angle	89.96 Degrees Standard Deviation 1.39	90.06 Degrees Standard Deviation 1.83

SECONDARY outcome

Timeframe: 2 year time point

Population: Subjects at 2 year within safety population with complete, available data

Tibial component angle measured at 2 year time point. This angle is measured between a line drawn from the center of the femoral head tibial implant.

Outcome measures

Measure	Sigma CR 150 n=80 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=77 Participants Subjects who received a Sigma CR implant
Alignment - Tibial Component to Anatomic Angle	89.69 Degrees Standard Deviation 1.60	90.19 Degrees Standard Deviation 1.98

SECONDARY outcome

Timeframe: 1 year time point

Population: Subjects at 1 year within safety population with complete, available data

Femoral Component Flexion measured at 1 year time point. This measures the angle between a line drawn though the center of the side of the femur and a line drawn across the top of the flat inner surface of the femoral component.

Outcome measures

Measure	Sigma CR 150 n=82 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=80 Participants Subjects who received a Sigma CR implant
Alignment - Femoral Component Flexion	89.74 Degrees Standard Deviation 2.44	90.10 Degrees Standard Deviation 2.12

SECONDARY outcome

Timeframe: 2 year time point

Population: Subjects at 2 years within safety population with complete, available data

Alignment - Femoral Component Flexion measured at 2 year time point. This measures the angle between a line drawn though the center of the side of the femur and a line drawn across the top of the flat inner surface of the femoral component.

Outcome measures

Measure	Sigma CR 150 n=80 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=77 Participants Subjects who received a Sigma CR implant
Alignment - Femoral Component Flexion	89.93 Degrees Standard Deviation 2.35	89.80 Degrees Standard Deviation 2.99

SECONDARY outcome

Timeframe: 1 year time point

Population: Subjects at 1 year within safety population with complete, available data

Tibial Posterior Slope measured at 1 year time point. This angle is measured between a line through the center of the side of the tibia and the top flat surface of the tibial implant

Outcome measures

Measure	Sigma CR 150 n=82 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=80 Participants Subjects who received a Sigma CR implant
Alignment - Tibial Posterior Slope	85.95 Degrees Standard Deviation 2.25	85.47 Degrees Standard Deviation 2.62

SECONDARY outcome

Timeframe: 2 year time point

Population: Subjects at 2 years within safety population with complete, available data

Alignment - Tibial Posterior Slope measured at 2 year time point. This angle is measured between a line through the center of the side of the tibia and the top flat surface of the tibial implant

Outcome measures

Measure	Sigma CR 150 n=80 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=76 Participants Subjects who received a Sigma CR implant
Alignment - Tibial Posterior Slope	85.99 Degrees Standard Deviation 2.29	85.15 Degrees Standard Deviation 3.24

SECONDARY outcome

Timeframe: 6 to 12 week and 24 month intervals

Population: Subjects within safety population with complete, available data

The bone-implant interface at the femoral components were examined radiographically and radiolucencies were measured in millimeters.

Radiolucent lines (RLLs) greater than 2mm are considered to be clinically significant.

Outcome measures

Measure	Sigma CR 150 n=90 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=88 Participants Subjects who received a Sigma CR implant
Number of Subjects With Radiolucencies - Femoral Component 6 Weeks to 12 Weeks	0 Participants	2 Participants
Number of Subjects With Radiolucencies - Femoral Component 24 months	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 weeks to 24 months

Population: Subjects within safety population with complete, available data

The bone-implant interface at the tibial components were examined radiographically and radiolucencies were measured in millimeters.

Radiolucent lines (RLLs) greater than 2mm are considered to be clinically significant.

Radiolucent lines greater than 2mm are considered to be clinically significant.

Outcome measures

Measure	Sigma CR 150 n=90 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=88 Participants Subjects who received a Sigma CR implant
Number of Subjects With Radiolucencies - Tibial Component 6 Weeks to 12 Weeks	0 Participants	1 Participants
Number of Subjects With Radiolucencies - Tibial Component 12 months	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 year time point

Population: Subjects at 1 year within safety population with complete, available data

Maximum knee flexion measured radiographically at 1 year time point

Outcome measures

Measure	Sigma CR 150 n=74 Participants Subjects who received a Sigma CR 150 implant	Sigma CR n=70 Participants Subjects who received a Sigma CR implant
Radiographic Evaluation of Maximum Flexion	108.51 Degrees Standard Deviation 18.90	107.11 Degrees Standard Deviation 17.41

Adverse Events

CR 150

Serious events: 9 serious events

Other events: 14 other events

Deaths: 0 deaths

C-RET

Serious events: 8 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	CR 150 n=90 participants at risk Subjects who received a Sigma CR150 implant	C-RET n=88 participants at risk Subjects who received a Sigma CR implant
Nervous system disorders Cerebrovascular accident	1.1% 1/90 • Number of events 1 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	2.3% 2/88 • Number of events 2 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/90 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	1.1% 1/88 • Number of events 1 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals
Gastrointestinal disorders Colitis ulcerative	1.1% 1/90 • Number of events 1 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	0.00% 0/88 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals
Musculoskeletal and connective tissue disorders Osteoarthritis	1.1% 1/90 • Number of events 1 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	1.1% 1/88 • Number of events 1 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/90 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	1.1% 1/88 • Number of events 1 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals
Infections and infestations Localised infection	0.00% 0/90 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	1.1% 1/88 • Number of events 1 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.00% 0/90 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	1.1% 1/88 • Number of events 2 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/90 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	1.1% 1/88 • Number of events 1 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 1/90 • Number of events 1 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	0.00% 0/88 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals
Musculoskeletal and connective tissue disorders Foot deformity	1.1% 1/90 • Number of events 1 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	0.00% 0/88 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals
Infections and infestations Bacterial sepsis	1.1% 1/90 • Number of events 1 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	0.00% 0/88 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals
Injury, poisoning and procedural complications Lumbar vertebral fracture	1.1% 1/90 • Number of events 1 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	0.00% 0/88 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals
Vascular disorders Deep vein thrombosis	1.1% 1/90 • Number of events 1 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	0.00% 0/88 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals
Infections and infestations Wound infection	1.1% 1/90 • Number of events 1 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	0.00% 0/88 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals

Other adverse events

Measure	CR 150 n=90 participants at risk Subjects who received a Sigma CR150 implant	C-RET n=88 participants at risk Subjects who received a Sigma CR implant
Musculoskeletal and connective tissue disorders Osteoarthritis	15.6% 14/90 • Number of events 14 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals	15.9% 14/88 • Number of events 14 • 2 years Adverse events were evaluated during clinic visits at protocol-defined post-operative intervals

Additional Information

Dave Whalen

DePuy Synthes

Phone: 574-372-7028

Email: dwhalen@its.jnj.com

Results disclosure agreements

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

Restriction type: LTE60