Non-inflammatory Degenerative Joint DiseaseNCT02650284
A Trial Evaluating TKR Compared to BKR Performed Using Stryker's Mako Robot
A study testing Stryker Triathlon Primary Total Knee System and Restoris MCK Multicompartmental Knee System in people with Non-inflammatory Degenerative Joint Disease, run by Stryker South Pacific at 1 site in Australia.
Trial summary
A prospective, randomised controlled trial evaluating Total Knee Replacement with the Stryker Triathlon Primary Total Knee System, compared to Bicompartmental Knee Replacement with Restoris MCK Multicompartmental Knee System performed using Stryker's Robotic-arm assisted surgery system, Mako. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-inflammatory Degenerative Joint Disease
- What is being tested?
- Stryker Triathlon Primary Total Knee System and Restoris MCK Multicompartmental Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Aug 2015to 6 Mar 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is a suitable candidate for a Bicompartmental Knee Replacement and has moderate to severe patellofemoral wear and medial compartment wear (surgeons discretion)
- The patient has no fixed flexion greater than 10 degrees.
- The patient has maximal flexion greater than 100 degrees
- The patient has a passively correctable varus deformity
- The patient has a functionally Intact Anterior Cruciate Ligament (ACL.)
- The patient has no significant patellofemoral malalignment
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- The patient has negligible lateral compartment degeneration with no appreciable loss of cartilage height (surgeon's discretion).
- The patient has pain that is not localised to the medial compartment only
- The patient is a male or non-pregnant female.
- The patient has signed the study specific, Human Research Ethics Committee (HREC)- approved Informed Consent document and 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 clinically deficient ACL and cruciate and collateral ligament insufficiency on CT arthrogram.
- The patient is undergoing revision surgery
- The patient has greater than 10° of hyperextension, greater than 10° of varus or valgus deformity, greater than 10° Flexion Contracture
- The patient has active, local infection or previous intra-articular infection
- The patient has skeletal immaturity
- The patient is without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis
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- The patient's weight, age or activity level might cause extreme loads and early failure of the system (surgeons discretion).
- The patient has a systemic or local condition that would limit the ability to assess the performance of the device e.g. neuromuscular or neurosensory deficiency, disorder leading to progressive bone deterioration (including rheumatoid arthritis and osteoporosis), or patient is immunologically suppressed.
- Patient has a cognitive impairment, an intellectual disability or a mental illness that is considered by the investigator to inhibit the patient's capacity to consent to research and the ability to participate in it
- Patients with tricompartmental disease are contraindicated from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomised Controlled Trial Evaluating Total Knee Replacement With the Stryker Triathlon Primary Total Knee System Performed Using Stryker's Robotic-arm Assisted Surgery System, Mako, Compared to Bicompartmental Knee Replacement With Restoris MCK Multicompartmental Knee System Performed Using Stryker's Robotic-arm Assisted Surgery System, Mako
A prospective, randomised controlled trial evaluating Total Knee Replacement with the Stryker Triathlon Primary Total Knee System, compared to Bicompartmental Knee Replacement with Restoris MCK Multicompartmental Knee System performed using Stryker's Robotic-arm assisted surgery system, Mako.
Read the detailed description
This study is a prospective, randomised clinical study comparing clinical outcomes of Knee Replacement using the Oxford Knee Score (OKS), in patients receiving either Bicompartmental Knee Replacement performed using Stryker's robotic-arm assisted surgery system Mako, to Total Knee Replacement using the Triathlon Total Knee System performed with either conventional instrumentation or navigation. Functional and radiographic outcomes will be additionally collected as part of this study.
- Being tested
- Stryker Triathlon Primary Total Knee System, Restoris MCK Multicompartmental Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stryker Triathlon Primary Total Knee SystemDevice
Total Knee Replacement
Restoris MCK Multicompartmental Knee SystemDevice
Bicompartmental Knee Replacement
| Study group | Role | What they receive |
|---|---|---|
| Bicompartmental Knee Replacement (BKR) | Other | Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Receives: Device: Restoris MCK Multicompartmental Knee System |
| Total Knee Replacement (TKR) | Other | Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Receives: Device: Stryker Triathlon Primary Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score
Comparing clinical outcomes using the Oxford Knee Score. 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: pre-op, 6 weeks, 3 months, 12 months, 24 months
Secondary outcomes (6)
Health Related Quality of Life EQ-5D
Comparing functional and clinical outcomes using the EQ-5D. 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. Index values range from 0-1, with 1 being representing "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'. The VAS scales represents health on the day.
Measured: 24 months/ 2years
VAS Pain
Comparing functional and clinical outcomes using the VAS pain. Pain at rest and pain during mobilization are measured using a 10 centimeter Visual Analogue Scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 100 being the worst pain.
Measured: 24 months/ 2years
New Knee Society Score (KSS)
Comparing functional and clinical outcomes using the KSS. 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: 24 months/ 2years
Forgotten Joint Score (FJS)
Comparing functional and clinical outcomes using the FJS. 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: 24 months/ 2years
Incidence of Loosening, Reoperation and Revision
To compare incidence of loosening, reoperation and revision rates. The incidence (ie number of participants who experienced lossening, reoperation or revision) will be counted and presented as a whole number or percentage of the total number of patients, however they will be identified from analysing Xrays and checking Serious Adverse Event/ Adverse Event reports.
Measured: 6 weeks, 3 months, 12 months, 24 months
Length of Hospital Stay
To compare length of hospital stay between the two arms of the study
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study start12 Aug 2015
- Primary completion6 Mar 2019
- Study completion6 Mar 2019
Why it stopped: Participant recruitment difficulties. Ruling to terminate study made Oct 2019
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.
- Other trials for Non-inflammatory Degenerative Joint DiseaseStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker South Pacific
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gavin Clark, Dr, Principal investigator, Perth Hip and Knee and St John of God Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650284
- Sponsor's protocol ID
- MAKORCT-15
- Status last verified
- Jun 2022
- First submitted
- 6 Jan 2016
- Last updated
- 29 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised Controlled Trial Evaluating Total Knee Replacement With the Stryker Triathlon Primary Total Knee System Performed Using Stryker's Robotic-arm Assisted Surgery System, Mako, Compared to Bicompartmental Knee Replacement With Restoris MCK Multicompartmental Knee System Performed Using Stryker's Robotic-arm Assisted Surgery System, Mako
- ClinicalTrials.gov ID
- NCT02650284
- Acronym / sponsor ID
- MAKORCT-15
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participant recruitment difficulties. Ruling to terminate study made Oct 2019
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Stryker South PacificIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2015 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Posted 4 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, randomised controlled trial evaluating Total Knee Replacement with the Stryker Triathlon Primary Total Knee System, compared to Bicompartmental Knee Replacement with Restoris MCK Multicompartmental Knee System performed using Stryker's Robotic-arm assisted surgery system, Mako.
Detailed description
This study is a prospective, randomised clinical study comparing clinical outcomes of Knee Replacement using the Oxford Knee Score (OKS), in patients receiving either Bicompartmental Knee Replacement performed using Stryker's robotic-arm assisted surgery system Mako, to Total Knee Replacement using the Triathlon Total Knee System performed with either conventional instrumentation or navigation. Functional and radiographic outcomes will be additionally collected as part of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bicompartmental Knee Replacement (BKR) | Other | Device: Restoris MCK Multicompartmental Knee SystemReceiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako |
| Total Knee Replacement (TKR) | Other | Device: Stryker Triathlon Primary Total Knee SystemReceiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient is a suitable candidate for a Bicompartmental Knee Replacement and has moderate to severe patellofemoral wear and medial compartment wear (surgeons discretion)
- The patient has no fixed flexion greater than 10 degrees.
- The patient has maximal flexion greater than 100 degrees
- The patient has a passively correctable varus deformity
- The patient has a functionally Intact Anterior Cruciate Ligament (ACL.)
Key exclusion criteria (10 listed)
- The patient has a clinically deficient ACL and cruciate and collateral ligament insufficiency on CT arthrogram.
- The patient is undergoing revision surgery
- The patient has greater than 10° of hyperextension, greater than 10° of varus or valgus deformity, greater than 10° Flexion Contracture
- The patient has active, local infection or previous intra-articular infection
- The patient has skeletal immaturity
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 |
|---|---|---|
| Stryker Triathlon Primary Total Knee SystemTotal Knee Replacement | Device | Total Knee Replacement (TKR) |
| Restoris MCK Multicompartmental Knee SystemBicompartmental Knee Replacement | Device | Bicompartmental Knee Replacement (BKR) |
Primary outcome
Oxford Knee Score
Time frame: pre-op, 6 weeks, 3 months, 12 months, 24 months
Comparing clinical outcomes using the Oxford Knee Score. 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.
6 secondary outcomes
Health Related Quality of Life EQ-5D
Time frame: 24 months/ 2years
VAS Pain
Time frame: 24 months/ 2years
New Knee Society Score (KSS)
Time frame: 24 months/ 2years
Forgotten Joint Score (FJS)
Time frame: 24 months/ 2years
Incidence of Loosening, Reoperation and Revision
Time frame: 6 weeks, 3 months, 12 months, 24 months
Length of Hospital Stay
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gavin Clark, Dr principal investigator
Perth Hip and Knee and St John of God Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stryker Triathlon Primary Total Knee System and Restoris MCK Multicompartmental Knee System in people with Non-inflammatory Degenerative Joint Disease, run by Stryker South Pacific at 1 site in Australia.
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 10 inclusion and 10 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: stopped early, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 Jun 2021). 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: pre-op, 6 weeks, 3 months, 12 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2022.