ArthroplastiesNCT02527148
A Trial of Mechanical Axis vs Kinematic Alignment in Total Knee Replacement
A study testing OtisMed® ShapeMatch® Technology, Stryker Precision Knee Navigation and Total Knee Replacement in people with Arthroplasties and Knee Replacement, run by Stryker South Pacific.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Arthroplasties, Knee Replacement
- What is being tested?
- OtisMed® ShapeMatch® Technology, Stryker Precision Knee Navigation and Total Knee Replacement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 4 Aug 2011to 19 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is a male or non-pregnant female between the ages of 40-80 years.
- The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
- Patient is deemed appropriate for a cruciate retaining knee replacement.
- The patient has a primary diagnosis of osteoarthritis (OA).
- The patient has intact collateral ligaments.
- The patient is able to undergo MRI scanning of the affected limb.
- The patient has signed the study specific, ethics-approved, Informed Consent document.
- The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
Who cannot join
- The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
- Patient has had a previous osteotomy around the knee.
- The patient is morbidly obese (BMI ≥ 40).
- The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
- The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis).
- The patient has a fixed flexion deformity ≥ 15°.
Show all 13Show fewer
- The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
- The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
- Patient has a cognitive impairment, an intellectual disability or a mental illness.
- The patient is pregnant.
- The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
- The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).
About this study
Official title: A Prospective, Randomized, Controlled Trial of Mechanical Axis vs Kinematic Alignment in TKR - With a Follow-up, Longitudinal Study of the Clinical and Radiographic Outcomes
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.
- Conditions
- Arthroplasties, Knee Replacement
- Being tested
- OtisMed® ShapeMatch® Technology, Stryker Precision Knee Navigation, Total Knee Replacement, Stryker Triathlon® Total Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtisMed® ShapeMatch® TechnologyDevice
The appropriate Stryker ShapeMatch® Cutting Guides will be used to guide the surgeons bone resections. The surgeon will implant the knee prostheses following the surgical protocol for Triathlon® Knee System with OtisMed® ShapeMatch® Technology
Stryker Precision Knee NavigationDevice
Stryker PrecisioN Knee (4.0) Navigation System, comprising of computer hardware and software and associated instrumentation, will be used for intra-operative alignment and orientation of implant. Navigation trackers will be secured to the femur and tibia and registration of the limb will be undertaken according to the PrecisioN Knee System surgical technique.Femoral and tibial resections, followed by device implantation, will be performed according to the Triathlon Knee System Surgical Protocol.
Total Knee ReplacementProcedure or surgery
Stryker Triathlon® Total Knee SystemDevice
Prosthetic components to be implanted including
- Triathlon® Cruciate Retaining (CR) Total Knee System (cemented), including Femoral Component and Primary Tibial Baseplate;
- Triathlon® Cruciate Substituting (CS) X3® polyethylene insert;
- Triathlon® X3 Patella (asymmetric) - treated selectively by surgeon.
| Study group | Role | What they receive |
|---|---|---|
| OtisMed® ShapeMatch® with Triathlon | Active comparator | Participants randomised to the Intervention Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology with the goal of kinematic alignment (re-aligning the limb to its pre-disease kinematic alignment). Receives: Device: OtisMed® ShapeMatch® Technology; Procedure: Total Knee Replacement; Device: Stryker Triathlon® Total Knee System |
| Stryker Precision Knee Navigation | Active comparator | Participants randomised to the Control Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation with the goal of neutral alignment to the mechanical axis. This is the standard method for TKR with Triathlon® Knee System and this group will serve as a control reference for the intervention group. Receives: Device: Stryker Precision Knee Navigation; Procedure: Total Knee Replacement; Device: Stryker Triathlon® Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score
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.
Measured: Preoperatively, 6-week, 6-months, 12 months, 2 years and 5 years postoperatively
Secondary outcomes (11)
Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time)
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.
Measured: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
Cost Effectiveness: Wound Length
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.
Measured: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
Cost Effectiveness: Cost of Consumable Items Used During Operating Procedure
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.
Measured: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
Cost Effectiveness: Length of Stay in Hospital
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..
Measured: 14 days
Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L
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.
Measured: 12 months
Knee Pain
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.
Measured: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
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.
Measured: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively
Health-related Quality of Life (EQ-5D-3L)
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'.
Measured: Preoperatively, 6-week, 6-month and 12 month visits, 2 years and 5 years
The Forgotten Joint Score (FJS-12)
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).
Measured: 6 week, 6 month, 12 month , 2 years and 5 years visits
The International Knee Society Score (IKSS)
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.
Measured: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively
Perth CT Protocol
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start4 Aug 2011
- Primary completion9 Apr 2018
- Study completion19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthroplastiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker South Pacific
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527148
- Sponsor's protocol ID
- ShapeNZRCT-10
- Status last verified
- May 2025
- First submitted
- 3 Aug 2015
- Last updated
- 15 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gibbons JP, Zeng N, Bayan A, Walker ML, Farrington B, Young SW. No Difference in 10-year Clinical or Radiographic Outcomes Between Kinematic and Mechanical Alignment in TKA: A Randomized Trial. Clin Orthop Relat Res. 2025 Jan 1;483(1):140-149. doi: 10.1097/CORR.0000000000003193. Epub 2024 Aug 14.
PubMed 39145997
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Trial of Mechanical Axis vs Kinematic Alignment in TKR - With a Follow-up, Longitudinal Study of the Clinical and Radiographic Outcomes
- ClinicalTrials.gov ID
- NCT02527148
- Acronym / sponsor ID
- ShapeNZRCT-10
- Conditions
- Arthroplasties, Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Stryker South PacificIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2011 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Posted 12 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OtisMed® ShapeMatch® with Triathlon | Active comparator | Device: OtisMed® ShapeMatch® Technology, Procedure: Total Knee Replacement, Device: Stryker Triathlon® Total Knee SystemParticipants randomised to the Intervention Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology with the goal of kinematic alignment (re-aligning the limb to its pre-disease kinematic alignment). |
| Stryker Precision Knee Navigation | Active comparator | Device: Stryker Precision Knee Navigation, Procedure: Total Knee Replacement, Device: Stryker Triathlon® Total Knee SystemParticipants randomised to the Control Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation with the goal of neutral alignment to the mechanical axis. This is the standard method for TKR with Triathlon® Knee System and this group will serve as a control reference for the intervention group. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient is a male or non-pregnant female between the ages of 40-80 years.
- The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
- Patient is deemed appropriate for a cruciate retaining knee replacement.
- The patient has a primary diagnosis of osteoarthritis (OA).
- The patient has intact collateral ligaments.
Key exclusion criteria (13 listed)
- The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
- Patient has had a previous osteotomy around the knee.
- The patient is morbidly obese (BMI ≥ 40).
- The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
- The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtisMed® ShapeMatch® TechnologyThe appropriate Stryker ShapeMatch® Cutting Guides will be used to guide the surgeons bone resections. The surgeon will implant the knee prostheses following the surgical protocol for Triathlon® Knee System with OtisMed® ShapeMatch® Technology | Device | OtisMed® ShapeMatch® with Triathlon |
| Stryker Precision Knee NavigationStryker PrecisioN Knee (4.0) Navigation System, comprising of computer hardware and software and associated instrumentation, will be used for intra-operative alignment and orientation of implant. Navigation trackers will be secured to the femur and tibia and registration of the limb will be undertaken according to the PrecisioN Knee System surgical technique.Femoral and tibial resections, followed by device implantation, will be performed according to the Triathlon Knee System Surgical Protocol. | Device | Stryker Precision Knee Navigation |
| Total Knee Replacement | Procedure or surgery | OtisMed® ShapeMatch® with Triathlon, Stryker Precision Knee Navigation |
| Stryker Triathlon® Total Knee SystemProsthetic components to be implanted including * Triathlon® Cruciate Retaining (CR) Total Knee System (cemented), including Femoral Component and Primary Tibial Baseplate; * Triathlon® Cruciate Substituting (CS) X3® polyethylene insert; * Triathlon® X3 Patella (asymmetric) - treated selectively by surgeon. | Device | OtisMed® ShapeMatch® with Triathlon, Stryker Precision Knee Navigation |
Primary outcome
Oxford Knee Score
Time frame: 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 scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.
11 secondary outcomes
Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time)
Time frame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
Cost Effectiveness: Wound Length
Time frame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
Cost Effectiveness: Cost of Consumable Items Used During Operating Procedure
Time frame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
Cost Effectiveness: Length of Stay in Hospital
Time frame: 14 days
Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L
Time frame: 12 months
Knee Pain
Time frame: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively
Health-related Quality of Life (EQ-5D-3L)
Time frame: Preoperatively, 6-week, 6-month and 12 month visits, 2 years and 5 years
The Forgotten Joint Score (FJS-12)
Time frame: 6 week, 6 month, 12 month , 2 years and 5 years visits
The International Knee Society Score (IKSS)
Time frame: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively
Perth CT Protocol
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39145997Gibbons JP, Zeng N, Bayan A, Walker ML, Farrington B, Young SW. No Difference in 10-year Clinical or Radiographic Outcomes Between Kinematic and Mechanical Alignment in TKA: A Randomized Trial. Clin Orthop Relat Res. 2025 Jan 1;483(1):140-149. doi: 10.1097/CORR.0000000000003193. Epub 2024 Aug 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing OtisMed® ShapeMatch® Technology, Stryker Precision Knee Navigation and Total Knee Replacement in people with Arthroplasties and Knee Replacement, run by Stryker South Pacific.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Knee Score (time frame: Preoperatively, 6-week, 6-months, 12 months, 2 years and 5 years postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02527148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.