Who is sponsoring NCT02527148?

NCT02527148 is sponsored by Stryker South Pacific.

What drugs are being tested in NCT02527148?

Interventions in NCT02527148: OtisMed® ShapeMatch® Technology, Stryker Precision Knee Navigation, Total Knee Replacement, Stryker Triathlon® Total Knee System.

What condition does NCT02527148 study?

NCT02527148 studies Arthroplasties, Knee Replacement.

Is NCT02527148 still recruiting?

NCT02527148 is currently completed. Last updated 15 May 2025.

Are results published for NCT02527148?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-05-15 · How we verify

NCT02527148

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial of Mechanical Axis vs Kinematic Alignment in Total Knee Replacement

Completed NA Results posted Last updated 15 May 2025

What this trial tests

NA trial testing OtisMed® ShapeMatch® Technology in Arthroplasties in 100 participants. Completed in 19 December 2018.

Timeline

4 August 2011

Primary endpoint
9 April 2018

19 December 2018

Quick facts

Lead sponsor	Stryker South Pacific
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	4 August 2011
Primary completion	9 April 2018
Estimated completion	19 December 2018

Drugs / interventions tested

OtisMed® ShapeMatch® Technology
Stryker Precision Knee Navigation
Total Knee Replacement
Stryker Triathlon® Total Knee System

Conditions studied

Arthroplasties — all drugs for Arthroplasties →
Knee Replacement — all drugs for Knee Replacement →

Sponsor

Stryker South Pacific

Who can join

Adults 40 to 80, any sex, with Arthroplasties or Knee Replacement. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Oxford Knee Score Primary · Preoperatively, 6-week, 6-months, 12 months, 2 years and 5 years postoperatively

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 scor

Oxford preoperative

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	20.3	± 5.7
Stryker Precision Knee Navigation	21.1	± 6.2

Oxford 6 weeks

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	32.5	± 6.8
Stryker Precision Knee Navigation	32.8	± 7.7

Oxford 6 months

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	41.0	± 4.8
Stryker Precision Knee Navigation	38.2	± 7.3

Oxford 12 months

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	41.8	± 6.1
Stryker Precision Knee Navigation	43.0	± 7.7

Oxford 2 years

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	42.1	± 6.1
Stryker Precision Knee Navigation	41.1	± 6.0

Oxford 5 years

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	41.4	± 7.2
Stryker Precision Knee Navigation	41.7	± 6.3

Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time) Secondary · 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.

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	82.6	± 26
Stryker Precision Knee Navigation	92.2	± 32

Cost Effectiveness: Wound Length Secondary · 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.

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	223	± 29
Stryker Precision Knee Navigation	233	± 34

Cost Effectiveness: Length of Stay in Hospital Secondary · 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..

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	5.1	± 3.0
Stryker Precision Knee Navigation	4.2	± 4.2

Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L Secondary · 12 months

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.

Preoperative QALY

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	0.507	± 0.17
Stryker Precision Knee Navigation	0.484	± 0.21

12 Month QALY

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	0.895	± 0.16
Stryker Precision Knee Navigation	0.852	± 0.19

Knee Pain Secondary · Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively

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.

Pre-op Pain at Rest

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	4.36	± 2.03
Stryker Precision Knee Navigation	4.20	± 2.48

Pre-op Pain at Mobilisation

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	5.78	± 2.32
Stryker Precision Knee Navigation	6.01	± 2.49

6-week Pain at Rest

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	1.95	± 1.93
Stryker Precision Knee Navigation	1.79	± 2.01

6-week Pain at Mobilisation

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	2.51	± 2.11
Stryker Precision Knee Navigation	2.49	± 2.00

6-month Pain at Rest

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	0.97	± 1.78
Stryker Precision Knee Navigation	1.20	± 2.04

6-month Pain at Mobilisation

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	1.15	± 1.97
Stryker Precision Knee Navigation	1.50	± 2.38

1-year Pain at Rest

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	0.53	± 1.35
Stryker Precision Knee Navigation	0.84	± 1.63

1-year Pain at Mobilisation

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	0.79	± 1.83
Stryker Precision Knee Navigation	1.35	± 2.3

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Secondary · Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively

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.

Pre-op

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	50.05	± 13.07
Stryker Precision Knee Navigation	50.36	± 14.91

6-week

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	74.74	± 11.75
Stryker Precision Knee Navigation	73.06	± 17.61

6-month

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	87.89	± 9.73
Stryker Precision Knee Navigation	81.79	± 15.94

1-year

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	90.86	± 11.14
Stryker Precision Knee Navigation	86.79	± 14.93

2-year

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	88.36	± 13.60
Stryker Precision Knee Navigation	85.46	± 16.79

5-year

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	86.13	± 15.49
Stryker Precision Knee Navigation	89.14	± 15.11

Health-related Quality of Life (EQ-5D-3L) Secondary · Preoperatively, 6-week, 6-month and 12 month visits, 2 years and 5 years

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= t

Pre-op EQ-5D Index

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	0.51	± 0.17
Stryker Precision Knee Navigation	0.48	± 0.21

Pre-op EQ-5D VAS

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	71.43	± 18.11
Stryker Precision Knee Navigation	75.66	± 14.28

6-week EQ-5D Index

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	0.67	± 0.14
Stryker Precision Knee Navigation	0.68	± 0.18

6-week EQ-5D VAS

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	79.38	± 13.58
Stryker Precision Knee Navigation	80.28	± 19.41

6-month EQ-5D Index

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	0.82	± 0.18
Stryker Precision Knee Navigation	0.78	± 0.2

6-month EQ-5D VAS

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	86.00	± 13.86
Stryker Precision Knee Navigation	84.04	± 14.52

1-year EQ-5D Index

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	0.89	± 0.16
Stryker Precision Knee Navigation	0.84	± 0.20

1-year EQ-5D VAS

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	85.48	± 12.46
Stryker Precision Knee Navigation	85.91	± 12.22

The Forgotten Joint Score (FJS-12) Secondary · 6 week, 6 month, 12 month , 2 years and 5 years visits

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).

6 week

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	58.12	± 25.53
Stryker Precision Knee Navigation	57.21	± 29.32

6 month

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	60.47	± 29.57
Stryker Precision Knee Navigation	59.96	± 28.27

12 month

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	62.47	± 28.99
Stryker Precision Knee Navigation	62.01	± 24.84

2 year

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	69.21	± 25.93
Stryker Precision Knee Navigation	66.22	± 25.54

5 year

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	68.04	± 28.824
Stryker Precision Knee Navigation	74.12	± 23.38

The International Knee Society Score (IKSS) Secondary · Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively

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.

Pre-op IKSS Pain

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	40.20	± 15.87
Stryker Precision Knee Navigation	37.33	± 14.82

Pre-op IKSS Function

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	54.06	± 15.70
Stryker Precision Knee Navigation	55.50	± 14.82

Pre-op Range of Motion

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	118.07	± 11.27
Stryker Precision Knee Navigation	116.17	± 15.51

6 week IKSS Pain

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	63.02	± 15.37
Stryker Precision Knee Navigation	58.30	± 18.28

6 week IKSS Function

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	63.33	± 16.90
Stryker Precision Knee Navigation	64.26	± 22.26

6 week Range of Motion

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	108.64	± 17.58
Stryker Precision Knee Navigation	107.28	± 14.99

6 month IKSS Pain

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	76.32	± 12.72
Stryker Precision Knee Navigation	68.77	± 18.81

6 month IKSS Function

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	82.17	± 17.72
Stryker Precision Knee Navigation	76.85	± 21.30

Perth CT Protocol Secondary · 3 months

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

Coronal mechanical axis:hip knee ankle angle

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	-0.4	± 3.5
Stryker Precision Knee Navigation	-0.7	± 2.0

Coronal angle fem comp and mech axis femur

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	2.0	± 2.6
Stryker Precision Knee Navigation	0.6	± 1.6

Coronal angle tibial comp and mech axis tibia

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	-2.8	± 3.1
Stryker Precision Knee Navigation	-0.7	± 1.9

Sagital tibial component slope

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	3.6	± 2.5
Stryker Precision Knee Navigation	1.3	± 2.4

Femcomp rotationrelative to surg epicond axis+=ER

Group	Value	95% CI
OtisMed® ShapeMatch® With Triathlon	-0.5	± 2.5
Stryker Precision Knee Navigation	1.5	± 2.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 5-years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

OtisMed® ShapeMatch® With Triathlon

Serious: 39/49 (80%)

Deaths: 0/49

Stryker Precision Knee Navigation

Serious: 38/50 (76%)

Deaths: 0/50

Serious adverse events (30 terms)

Reaction	System	OtisMed® ShapeMatch® With …	Stryker Precision Knee Nav…
Non-operative site	Surgical and medical procedures	—	—
Non-operative site	Musculoskeletal and connective tissue disorders	—	—
Non-operative site	Gastrointestinal disorders	—	—
Non-operative site	Infections and infestations	—	—
Non-operative site	Respiratory, thoracic and mediastinal disorders	—	—
Non-operative site	Cardiac disorders	—	—
Non-operative site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Non-operative site	Vascular disorders	—	—
Non-operative site	Eye disorders	—	—
Operative site	Surgical and medical procedures	—	—
Non-operative site	General disorders	—	—
Non-operative site	Hepatobiliary disorders	—	—
Operative site	Infections and infestations	—	—
Non-operative site	Renal and urinary disorders	—	—
Operative site	Musculoskeletal and connective tissue disorders	—	—
Non-operative site	Psychiatric disorders	—	—
Non-operative site	Skin and subcutaneous tissue disorders	—	—
Non-operative site	Injury, poisoning and procedural complications	—	—
Non-operative side	Nervous system disorders	—	—
Non-operative site	Reproductive system and breast disorders	—	—
Non-operative site	Blood and lymphatic system disorders	—	—
Non-operative site	Ear and labyrinth disorders	—	—
Operative site	Investigations	—	—
Non-operative site	Metabolism and nutrition disorders	—	—
Non-operative site	Congenital, familial and genetic disorders	—	—

Other adverse events (11 terms — click to expand)

Reaction	System	OtisMed® ShapeMatch® With …	Stryker Precision Knee Nav…
Non-operative site	Musculoskeletal and connective tissue disorders	—	—
Non-operative site	Surgical and medical procedures	—	—
Operative site	Injury, poisoning and procedural complications	—	—
Non-operative site	Gastrointestinal disorders	—	—
Operative site	Product Issues	—	—
Non-operative site	Infections and infestations	—	—
Operative site	Musculoskeletal and connective tissue disorders	—	—
Non-operative site	Eye disorders	—	—
Non-operative site	General disorders	—	—
Non-operative site	Injury, poisoning and procedural complications	—	—
Non-operative site	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Non-operative site, Non-operative site, Non-operative site, Non-operative site, Non-operative site, Non-operative site, Non-operative site, Non-operative site.

Data from ClinicalTrials.gov NCT02527148 adverse events section.

Sponsor's own description

This is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. In this study ShapeMatch® cutting guides will be compared to the conventional approach.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

The Chitranjan S. Ranawat Award : No Difference in 2-year Functional Outcomes Using Kinematic versus Mechanical Alignment in TKA: A Randomized Controlled Clinical Trial.
Young SW, Walker ML, Bayan A, Briant-Evans T, et al · · 2017 · cited 161× · PMID 27113595 · DOI 10.1007/s11999-016-4844-x
No Difference in 5-year Clinical or Radiographic Outcomes Between Kinematic and Mechanical Alignment in TKA: A Randomized Controlled Trial.
Young SW, Sullivan NPT, Walker ML, Holland S, et al · · 2020 · cited 73× · PMID 32039955 · DOI 10.1097/corr.0000000000001150
No Difference in 10-year Clinical or Radiographic Outcomes Between Kinematic and Mechanical Alignment in TKA: A Randomized Trial.
Gibbons JP, Zeng N, Bayan A, Walker ML, et al · · 2025 · cited 17× · PMID 39145997 · DOI 10.1097/corr.0000000000003193

Verify or expand the search:

Other Stryker South Pacific trials

Trials by the same sponsor.

NCT02650284 — A Trial Evaluating TKR Compared to BKR Performed Using Stryker's Mako Robot · NA · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02527148 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stryker South Pacific
Last refreshed: 15 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02527148.

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