Trial Outcomes & Findings for A Trial of Mechanical Axis vs Kinematic Alignment in Total Knee Replacement (NCT NCT02527148)

Last Updated: 2025-05-15

Results Overview

To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated pre-operatively and at 6 weeks, 6 months, 12 months, 2 years and 5 years. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

Preoperatively, 6-week, 6-months, 12 months, 2 years and 5 years postoperatively

Results posted on

2025-05-15

Participant Flow

For all results participants=knees.

Participant milestones

Participant milestones
Measure	OtisMed® ShapeMatch® With Triathlon Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
Overall Study STARTED	50	50
Overall Study COMPLETED	49	50
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	OtisMed® ShapeMatch® With Triathlon Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
Overall Study Did not receive study intervention	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OtisMed® ShapeMatch® With Triathlon n=49 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation n=50 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.	Total n=99 Participants Total of all reporting groups
Age, Continuous	71.9 years STANDARD_DEVIATION 6.5 • n=49 Participants	69.6 years STANDARD_DEVIATION 7.5 • n=50 Participants	70.8 years STANDARD_DEVIATION 7.0 • n=99 Participants
Sex: Female, Male Female	25 Participants n=49 Participants	26 Participants n=50 Participants	51 Participants n=99 Participants
Sex: Female, Male Male	24 Participants n=49 Participants	24 Participants n=50 Participants	48 Participants n=99 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment New Zealand	49 participants n=49 Participants	50 participants n=50 Participants	99 participants n=99 Participants

PRIMARY outcome

Timeframe: Preoperatively, 6-week, 6-months, 12 months, 2 years and 5 years postoperatively

Population: Shapematch: 49 had preoperative,48 had 6 week, 46 had 6 months, 48 had 12 month, 49 had 2 year and 47 had 5 year scores. Navigation: 50 had preoperative, 47 had 6 week, 46 had 6 months, 49 had 12 month, 50 had 2 years and 48 had 5 years scores. Participants=knees

Outcome measures

Outcome measures
Measure	OtisMed® ShapeMatch® With Triathlon n=49 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation n=50 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
Oxford Knee Score Oxford preoperative	20.3 units on a scale Standard Deviation 5.7	21.1 units on a scale Standard Deviation 6.2
Oxford Knee Score Oxford 6 weeks	32.5 units on a scale Standard Deviation 6.8	32.8 units on a scale Standard Deviation 7.7
Oxford Knee Score Oxford 6 months	41.0 units on a scale Standard Deviation 4.8	38.2 units on a scale Standard Deviation 7.3
Oxford Knee Score Oxford 12 months	41.8 units on a scale Standard Deviation 6.1	43.0 units on a scale Standard Deviation 7.7
Oxford Knee Score Oxford 2 years	42.1 units on a scale Standard Deviation 6.1	41.1 units on a scale Standard Deviation 6.0
Oxford Knee Score Oxford 5 years	41.4 units on a scale Standard Deviation 7.2	41.7 units on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.

Skin to skin time is the time in minutes from initial skin incision to skin closure. Anaesthesia time is the time in minutes that anaesthesia administration is started to the time it is stopped. Data for anaesthesia time is not available due to an error on the original case report form that did not correctly capture anaesthesia time.

Outcome measures

Outcome measures
Measure	OtisMed® ShapeMatch® With Triathlon n=49 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation n=50 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time)	82.6 minutes Standard Deviation 26	92.2 minutes Standard Deviation 32

SECONDARY outcome

Timeframe: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.

To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the surgical incision length is reported in mm.

Outcome measures

Outcome measures
Measure	OtisMed® ShapeMatch® With Triathlon n=49 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation n=50 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
Cost Effectiveness: Wound Length	223 millimeters Standard Deviation 29	233 millimeters Standard Deviation 34

SECONDARY outcome

Timeframe: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.

Population: Cost effectiveness data is not available.

To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group. The data for the cost of consumable items used during the operating procedure is not available. Due to limited site resources, a decision was made not to collect this secondary outcome measure data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the length of stay in number of days spent in the hospital is reported..

Outcome measures

Outcome measures
Measure	OtisMed® ShapeMatch® With Triathlon n=49 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation n=50 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
Cost Effectiveness: Length of Stay in Hospital	5.1 days Standard Deviation 3.0	4.2 days Standard Deviation 4.2

SECONDARY outcome

Timeframe: 12 months

Population: Shapematch preoperative N=48, 12 month N=48. Navigation preoperative N=50, 12 month N-49.

A quality-adjusted life-year (QALY) takes into account both the quantity and quality of life generated by healthcare interventions. It is the arithmetic product of life expectancy and a measure of the quality of the remaining life-years. A QALY places a weight on time in different health states. A year of perfect health is worth 1 and a year of less than perfect health is worth less than 1. Death is considered to be equivalent to 0; however,some health states may be considered worse than death and have negative scores.

Outcome measures

Outcome measures
Measure	OtisMed® ShapeMatch® With Triathlon n=48 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation n=50 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L Preoperative QALY	0.507 QALY life year Standard Deviation 0.17	0.484 QALY life year Standard Deviation 0.21
Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L 12 Month QALY	0.895 QALY life year Standard Deviation 0.16	0.852 QALY life year Standard Deviation 0.19

SECONDARY outcome

Timeframe: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively

Population: Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points.

Pain at rest and pain during mobilization was measured using a 10 centimeter Visual Analogue Scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.

Outcome measures

Outcome measures
Measure	OtisMed® ShapeMatch® With Triathlon n=49 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation n=50 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
Knee Pain Pre-op Pain at Rest	4.36 score on a scale Standard Deviation 2.03	4.20 score on a scale Standard Deviation 2.48
Knee Pain Pre-op Pain at Mobilisation	5.78 score on a scale Standard Deviation 2.32	6.01 score on a scale Standard Deviation 2.49
Knee Pain 6-week Pain at Rest	1.95 score on a scale Standard Deviation 1.93	1.79 score on a scale Standard Deviation 2.01
Knee Pain 6-week Pain at Mobilisation	2.51 score on a scale Standard Deviation 2.11	2.49 score on a scale Standard Deviation 2.00
Knee Pain 6-month Pain at Rest	0.97 score on a scale Standard Deviation 1.78	1.20 score on a scale Standard Deviation 2.04
Knee Pain 6-month Pain at Mobilisation	1.15 score on a scale Standard Deviation 1.97	1.50 score on a scale Standard Deviation 2.38
Knee Pain 1-year Pain at Rest	0.53 score on a scale Standard Deviation 1.35	0.84 score on a scale Standard Deviation 1.63
Knee Pain 1-year Pain at Mobilisation	0.79 score on a scale Standard Deviation 1.83	1.35 score on a scale Standard Deviation 2.3
Knee Pain 2-year Pain at Rest	0.67 score on a scale Standard Deviation 0.94	1.00 score on a scale Standard Deviation 1.72
Knee Pain 2-year Pain at Mobilisation	1.14 score on a scale Standard Deviation 1.35	1.31 score on a scale Standard Deviation 1.84
Knee Pain 5-year Pain at Rest	0.84 score on a scale Standard Deviation 1.56	0.63 score on a scale Standard Deviation 1.07
Knee Pain 5-year Pain at Mobilisation	1.21 score on a scale Standard Deviation 1.64	1.17 score on a scale Standard Deviation 2.06

SECONDARY outcome

Timeframe: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively

Population: Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points.

The WOMAC is completed by the participant and measures five items for pain (score range 0-100), two for stiffness (score range 0-100), and 17 for functional limitation (score range 0-100). The total score is the sum of these three categories.

Outcome measures

Outcome measures
Measure	OtisMed® ShapeMatch® With Triathlon n=49 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation n=50 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pre-op	50.05 score on a scale Standard Deviation 13.07	50.36 score on a scale Standard Deviation 14.91
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) 6-week	74.74 score on a scale Standard Deviation 11.75	73.06 score on a scale Standard Deviation 17.61
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) 6-month	87.89 score on a scale Standard Deviation 9.73	81.79 score on a scale Standard Deviation 15.94
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) 1-year	90.86 score on a scale Standard Deviation 11.14	86.79 score on a scale Standard Deviation 14.93
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) 2-year	88.36 score on a scale Standard Deviation 13.60	85.46 score on a scale Standard Deviation 16.79
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) 5-year	86.13 score on a scale Standard Deviation 15.49	89.14 score on a scale Standard Deviation 15.11

SECONDARY outcome

Timeframe: Preoperatively, 6-week, 6-month and 12 month visits, 2 years and 5 years

Population: Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points.

The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The participant is asked to indicate his/her health state by indicating the most appropriate level for each of the 5 dimensions. Responses may be converted into a single summary index by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. The index can be calculated by deducting the appropriate weights from 1= the value for full health. The EQ VAS records the participant's self-rated health on a vertical, visual analogue scale where the endpoints are labelled from 100 ='Best imaginable health state' to 0= 'Worst imaginable health state'.

Outcome measures

Outcome measures
Measure	OtisMed® ShapeMatch® With Triathlon n=49 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation n=50 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
Health-related Quality of Life (EQ-5D-3L) Pre-op EQ-5D Index	0.51 score on a scale Standard Deviation 0.17	0.48 score on a scale Standard Deviation 0.21
Health-related Quality of Life (EQ-5D-3L) Pre-op EQ-5D VAS	71.43 score on a scale Standard Deviation 18.11	75.66 score on a scale Standard Deviation 14.28
Health-related Quality of Life (EQ-5D-3L) 6-week EQ-5D Index	0.67 score on a scale Standard Deviation 0.14	0.68 score on a scale Standard Deviation 0.18
Health-related Quality of Life (EQ-5D-3L) 6-week EQ-5D VAS	79.38 score on a scale Standard Deviation 13.58	80.28 score on a scale Standard Deviation 19.41
Health-related Quality of Life (EQ-5D-3L) 6-month EQ-5D Index	0.82 score on a scale Standard Deviation 0.18	0.78 score on a scale Standard Deviation 0.2
Health-related Quality of Life (EQ-5D-3L) 6-month EQ-5D VAS	86.00 score on a scale Standard Deviation 13.86	84.04 score on a scale Standard Deviation 14.52
Health-related Quality of Life (EQ-5D-3L) 1-year EQ-5D Index	0.89 score on a scale Standard Deviation 0.16	0.84 score on a scale Standard Deviation 0.20
Health-related Quality of Life (EQ-5D-3L) 1-year EQ-5D VAS	85.48 score on a scale Standard Deviation 12.46	85.91 score on a scale Standard Deviation 12.22
Health-related Quality of Life (EQ-5D-3L) 2-year EQ-5D Index	0.77 score on a scale Standard Deviation 0.30	0.70 score on a scale Standard Deviation 0.30
Health-related Quality of Life (EQ-5D-3L) 2-year EQ-5D VAS	81.80 score on a scale Standard Deviation 18.57	84.70 score on a scale Standard Deviation 11.63
Health-related Quality of Life (EQ-5D-3L) 5-year EQ-5D Index	0.82 score on a scale Standard Deviation 0.20	0.86 score on a scale Standard Deviation 0.18
Health-related Quality of Life (EQ-5D-3L) 5-year EQ-5D VAS	78.21 score on a scale Standard Deviation 16.51	78.58 score on a scale Standard Deviation 17.02

SECONDARY outcome

Timeframe: 6 week, 6 month, 12 month , 2 years and 5 years visits

Population: Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points.

The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).

Outcome measures

Outcome measures
Measure	OtisMed® ShapeMatch® With Triathlon n=49 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation n=50 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
The Forgotten Joint Score (FJS-12) 6 week	58.12 score on a scale Standard Deviation 25.53	57.21 score on a scale Standard Deviation 29.32
The Forgotten Joint Score (FJS-12) 6 month	60.47 score on a scale Standard Deviation 29.57	59.96 score on a scale Standard Deviation 28.27
The Forgotten Joint Score (FJS-12) 12 month	62.47 score on a scale Standard Deviation 28.99	62.01 score on a scale Standard Deviation 24.84
The Forgotten Joint Score (FJS-12) 2 year	69.21 score on a scale Standard Deviation 25.93	66.22 score on a scale Standard Deviation 25.54
The Forgotten Joint Score (FJS-12) 5 year	68.04 score on a scale Standard Deviation 28.824	74.12 score on a scale Standard Deviation 23.38

SECONDARY outcome

Timeframe: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively

Population: Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points.

The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.

Outcome measures

Outcome measures
Measure	OtisMed® ShapeMatch® With Triathlon n=49 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation n=50 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
The International Knee Society Score (IKSS) 2 year Range of Motion	119.19 score on a scale Standard Deviation 11.91	117.63 score on a scale Standard Deviation 15.20
The International Knee Society Score (IKSS) 2 year IKSS Pain	73.67 score on a scale Standard Deviation 9.92	70.10 score on a scale Standard Deviation 16.32
The International Knee Society Score (IKSS) 2 year IKSS Function	83.06 score on a scale Standard Deviation 17.94	80.52 score on a scale Standard Deviation 23.00
The International Knee Society Score (IKSS) Pre-op IKSS Pain	40.20 score on a scale Standard Deviation 15.87	37.33 score on a scale Standard Deviation 14.82
The International Knee Society Score (IKSS) Pre-op IKSS Function	54.06 score on a scale Standard Deviation 15.70	55.50 score on a scale Standard Deviation 14.82
The International Knee Society Score (IKSS) Pre-op Range of Motion	118.07 score on a scale Standard Deviation 11.27	116.17 score on a scale Standard Deviation 15.51
The International Knee Society Score (IKSS) 6 week IKSS Pain	63.02 score on a scale Standard Deviation 15.37	58.30 score on a scale Standard Deviation 18.28
The International Knee Society Score (IKSS) 6 week IKSS Function	63.33 score on a scale Standard Deviation 16.90	64.26 score on a scale Standard Deviation 22.26
The International Knee Society Score (IKSS) 6 week Range of Motion	108.64 score on a scale Standard Deviation 17.58	107.28 score on a scale Standard Deviation 14.99
The International Knee Society Score (IKSS) 6 month IKSS Pain	76.32 score on a scale Standard Deviation 12.72	68.77 score on a scale Standard Deviation 18.81
The International Knee Society Score (IKSS) 6 month IKSS Function	82.17 score on a scale Standard Deviation 17.72	76.85 score on a scale Standard Deviation 21.30
The International Knee Society Score (IKSS) 6 month Range of Motion	117.24 score on a scale Standard Deviation 13.31	113.09 score on a scale Standard Deviation 21.31
The International Knee Society Score (IKSS) 12 month IKSS Pain	76.96 score on a scale Standard Deviation 14.65	73.29 score on a scale Standard Deviation 15.08
The International Knee Society Score (IKSS) 12 month IKSS Function	83.96 score on a scale Standard Deviation 17.38	80.82 score on a scale Standard Deviation 20.22
The International Knee Society Score (IKSS) 12 month Range of Motion	118.19 score on a scale Standard Deviation 12.69	116.57 score on a scale Standard Deviation 12.11
The International Knee Society Score (IKSS) 5 year IKSS Pain	73.26 score on a scale Standard Deviation 12.19	74.71 score on a scale Standard Deviation 8.95
The International Knee Society Score (IKSS) 5 year IKSS Function	80.96 score on a scale Standard Deviation 18.41	85.96 score on a scale Standard Deviation 16.64
The International Knee Society Score (IKSS) 5 year Range of Motion	122.24 score on a scale Standard Deviation 6.69	120.43 score on a scale Standard Deviation 9.16

SECONDARY outcome

Timeframe: 3 months

Population: Participants=knees

The Perth CT protocol is a comprehensive assessment of total knee replacement (TKR) component position and orientation. The alignment of the TKR components is measured against the mechanical axis and the transepicondylar axis of the lower extremity. The posted data represents the mean angle between the femoral component and mechanical axis of the femur, the angle between tibial component and mechanical axis of the tibia, the tibial component slope relative to the sagittal mechanical axis, and the femoral component rotation relative to surgical epicondylar axis (positive value=external rotation). For all degree values posted a positive (+) value= valgus and a negative (-) value = varus.

Outcome measures

Outcome measures
Measure	OtisMed® ShapeMatch® With Triathlon n=49 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation n=50 Participants Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
Perth CT Protocol Coronal mechanical axis:hip knee ankle angle	-0.4 degrees Standard Deviation 3.5	-0.7 degrees Standard Deviation 2.0
Perth CT Protocol Coronal angle fem comp and mech axis femur	2.0 degrees Standard Deviation 2.6	0.6 degrees Standard Deviation 1.6
Perth CT Protocol Coronal angle tibial comp and mech axis tibia	-2.8 degrees Standard Deviation 3.1	-0.7 degrees Standard Deviation 1.9
Perth CT Protocol Sagital tibial component slope	3.6 degrees Standard Deviation 2.5	1.3 degrees Standard Deviation 2.4
Perth CT Protocol Femcomp rotationrelative to surg epicond axis+=ER	-0.5 degrees Standard Deviation 2.5	1.5 degrees Standard Deviation 2.5

Adverse Events

OtisMed® ShapeMatch® With Triathlon

Serious events: 39 serious events

Other events: 24 other events

Deaths: 0 deaths

Stryker Precision Knee Navigation

Serious events: 38 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	OtisMed® ShapeMatch® With Triathlon n=49 participants at risk Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.	Stryker Precision Knee Navigation n=50 participants at risk Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
Injury, poisoning and procedural complications Operative site	12.2% 6/49 • Number of events 6 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.	0.00% 0/50 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.
Eye disorders Non-operative site	6.1% 3/49 • Number of events 3 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.	4.0% 2/50 • Number of events 2 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.
Gastrointestinal disorders Non-operative site	12.2% 6/49 • Number of events 7 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.	4.0% 2/50 • Number of events 3 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.
General disorders Non-operative site	0.00% 0/49 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.	6.0% 3/50 • Number of events 3 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.
Infections and infestations Non-operative site	4.1% 2/49 • Number of events 3 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.	10.0% 5/50 • Number of events 6 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.
Injury, poisoning and procedural complications Non-operative site	6.1% 3/49 • Number of events 3 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.	4.0% 2/50 • Number of events 2 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.
Musculoskeletal and connective tissue disorders Operative site	4.1% 2/49 • Number of events 2 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.	8.0% 4/50 • Number of events 4 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.
Musculoskeletal and connective tissue disorders Non-operative site	16.3% 8/49 • Number of events 12 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.	20.0% 10/50 • Number of events 14 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.
Product Issues Operative site	12.2% 6/49 • Number of events 6 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.	0.00% 0/50 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.
Respiratory, thoracic and mediastinal disorders Non-operative site	2.0% 1/49 • Number of events 1 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.	6.0% 3/50 • Number of events 3 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.
Surgical and medical procedures Non-operative site	14.3% 7/49 • Number of events 9 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.	12.0% 6/50 • Number of events 7 • 5-years Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.

Additional Information

David Fulker

Stryker South Pacific

Phone: +61 2 9467 1072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Discloser must give at least 40 days notice to Sponsor including a copy of the proposed publication. The Sponsor can then provide comments (which Discloser is not bound to follow), request delay of publication by no more than 120 days to allow for Sponsor to protect its intellectual property, or request that the Discloser remove certain proprietary or confidential information from the study (other than the results of the study).
Publication restrictions are in place

Restriction type: OTHER