Knee OsteoarthritisNCT03117959
TKA Using Patient-Specific Instrumentation
A study testing Stryker ShapeMatch Technology and Stryker Triathlon Custom Fit Knee in people with Knee Osteoarthritis, run by Queen's University at 1 site in Canada.
Trial summary
The purpose of our study is to determine if anatomic/kinematic total knee arthroplasties (TKAs) are superior to mechanical axis-referenced TKAs with respect to determinants of gait functionality, patient satisfaction and other objective tests of knee function as a potential indicator of long-term prosthesis outcomes. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Stryker ShapeMatch Technology and Stryker Triathlon Custom Fit Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged = 50-75
- BMI = 20 - 40
- Preoperative ability to perform certain gait tasks/skills
- No previous knee surgery or injury on either limb
- No neuromuscular disease or neurologic disease
- ASA of 1-2
Who cannot join
- below age 50 and/or above age 75
- BMI less than 20 or greater than 40
- ASA of 3 or higher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Trial Comparing an Anatomical Axis Aligned and Conventional Mechanical Axis Total Knee Arthroplasty Using Patient-Specific Instrumentation
The purpose of our study is to determine if anatomic/kinematic total knee arthroplasties (TKAs) are superior to mechanical axis-referenced TKAs with respect to determinants of gait functionality, patient satisfaction and other objective tests of knee function as a potential indicator of long-term prosthesis outcomes. To our knowledge there has not been any literature comparing TKAs using the kinematic and mechanical axes with respect to gait analysis. A single study has compared gender-specific TKAs and found that there is no difference with respect to determinants of gait when using these prostheses (Thomsen et al, 2012), but again this study was not based on referencing off of the anatomical/kinematic axis of the knee. Our group is hoping that the small variability that may be detectable with the precision of gait analysis may be used as a predictor of future prosthesis outcome measures.
Read the detailed description
The reference standard for total knee replacement or total knee arthroplasty (TKA) has historically been based on a 2-dimensional "mechanical axis" of the knee which surgically creates a joint line parallel to the ground. This is based on the idea that this alignment will evenly distribute the stress on the prosthesis, thus improving the wear characteristics and longevity of the replacement. More recent studies have shown that TKAs with greater than 3 degree deviation (in either valgus or varus) from this previously accepted ideal does not convey a survival benefit over a 15 year period. This is not to say that alignment does not play a role in survivorship as gross deviation from neutral does result in earlier implant failure, but a simple 2-D model may not be the ideal approach to TKAs. With the developments and improvements in patient-specific technology (or patient-specific instrumentation (PSI)), our ability to create TKAs that reproduce the patient's original anatomic or kinematic alignment in 3-Dimensions has dramatically improved. Early research with respect to function and survivorship has shown that PSIs are at least equivalent when compared to conventional TKAs. Some studies have also suggested improvements with respect to shorter operating times, less blood loss and increased range of motion. Most of the current PSI TKA literature has placed an emphasis on the technology's effect on TKA alignment or to show that it is bioequivalent with respect to range of motion or early prosthesis survivorship when compared to conventional TKAs. Although a single study using PSIs (Howell et al., 2013) has shown improvement in Oxford Knee Scores when comparing patients preoperatively to postoperatively, to our knowledge there is no research done to directly compare the functional knee scores between a mechanically-aligned and anatomically aligned TKA. This randomized control trial will compare these two approaches using implants from the same manufacturer and also hope to identify more subtle functional differences using power testing and gait analysis, in addition to assessing other perioperative outcomes such as blood loss, hospital stay duration and operative time.
- Conditions
- Knee Osteoarthritis
- Being tested
- Stryker ShapeMatch Technology, Stryker Triathlon Custom Fit Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stryker ShapeMatch TechnologyDevice
Will use this patient-specific guide for alignment with Stryker Triathlon Custom Fit Knee.
Stryker Triathlon Custom Fit KneeDevice
| Study group | Role | What they receive |
|---|---|---|
| Stryker Triathlon Custom Fit Knee | Placebo comparator | implanted in standard fashion Receives: Device: Stryker Triathlon Custom Fit Knee |
| Stryker shape match | Experimental | no longer RCT Receives: Device: Stryker ShapeMatch Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait analysis
Treadmill walk
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: no longer RCT - same surgical technique and implant used
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gavin Wood, Queen's University
- Investigators
- Gavin Wood, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117959
- Sponsor's protocol ID
- SURG-290-14
- Other IDs
- 6011807
- Status last verified
- Apr 2018
- First submitted
- 7 Apr 2014
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Comparing an Anatomical Axis Aligned and Conventional Mechanical Axis Total Knee Arthroplasty Using Patient-Specific Instrumentation
- ClinicalTrials.gov ID
- NCT03117959
- Acronym / sponsor ID
- SURG-290-14
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no longer RCT - same surgical technique and implant used
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of our study is to determine if anatomic/kinematic total knee arthroplasties (TKAs) are superior to mechanical axis-referenced TKAs with respect to determinants of gait functionality, patient satisfaction and other objective tests of knee function as a potential indicator of long-term prosthesis outcomes. To our knowledge there has not been any literature comparing TKAs using the kinematic and mechanical axes with respect to gait analysis. A single study has compared gender-specific TKAs and found that there is no difference with respect to determinants of gait when using these prostheses (Thomsen et al, 2012), but again this study was not based on referencing off of the anatomical/kinematic axis of the knee. Our group is hoping that the small variability that may be detectable with the precision of gait analysis may be used as a predictor of future prosthesis outcome measures.
Detailed description
The reference standard for total knee replacement or total knee arthroplasty (TKA) has historically been based on a 2-dimensional "mechanical axis" of the knee which surgically creates a joint line parallel to the ground. This is based on the idea that this alignment will evenly distribute the stress on the prosthesis, thus improving the wear characteristics and longevity of the replacement. More recent studies have shown that TKAs with greater than 3 degree deviation (in either valgus or varus) from this previously accepted ideal does not convey a survival benefit over a 15 year period. This is not to say that alignment does not play a role in survivorship as gross deviation from neutral does result in earlier implant failure, but a simple 2-D model may not be the ideal approach to TKAs. With the developments and improvements in patient-specific technology (or patient-specific instrumentation (PSI)), our ability to create TKAs that reproduce the patient's original anatomic or kinematic alignment in 3-Dimensions has dramatically improved. Early research with respect to function and survivorship has shown that PSIs are at least equivalent when compared to conventional TKAs. Some studies have also suggested improvements with respect to shorter operating times, less blood loss and increased range of motion. Most of the current PSI TKA literature has placed an emphasis on the technology's effect on TKA alignment or to show that it is bioequivalent with respect to range of motion or early prosthesis survivorship when compared to conventional TKAs. Although a single study using PSIs (Howell et al., 2013) has shown improvement in Oxford Knee Scores when comparing patients preoperatively to postoperatively, to our knowledge there is no research done to directly compare the functional knee scores between a mechanically-aligned and anatomically aligned TKA. This randomized control trial will compare these two approaches using implants from the same manufacturer and also hope to identify more subtle functional differences using power testing and gait analysis, in addition to assessing other perioperative outcomes such as blood loss, hospital stay duration and operative time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stryker Triathlon Custom Fit Knee | Placebo comparator | Device: Stryker Triathlon Custom Fit Kneeimplanted in standard fashion |
| Stryker shape match | Experimental | Device: Stryker ShapeMatch Technologyno longer RCT |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged = 50-75
- BMI = 20 - 40
- Preoperative ability to perform certain gait tasks/skills
- No previous knee surgery or injury on either limb
- No neuromuscular disease or neurologic disease
Key exclusion criteria (3 listed)
- below age 50 and/or above age 75
- BMI less than 20 or greater than 40
- ASA of 3 or higher
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 ShapeMatch TechnologyWill use this patient-specific guide for alignment with Stryker Triathlon Custom Fit Knee. | Device | Stryker shape match |
| Stryker Triathlon Custom Fit Knee | Device | Stryker Triathlon Custom Fit Knee |
Primary outcome
gait analysis
Time frame: 12 months
Treadmill walk
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- 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 Wood, MD principal investigator
Queen's University
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 ShapeMatch Technology and Stryker Triathlon Custom Fit Knee in people with Knee Osteoarthritis, run by Queen's University at 1 site in Canada.
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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 6 Apr 2018. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
gait analysis (time frame: 12 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 6 Apr 2018.