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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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.

Canada1 site
  • Hotel Dieu Hospital

    Kingston, Ontario, K7L 5G2

Other trials in Canada

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.

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 groups in NCT03117959
Study groupRoleWhat they receive
Stryker Triathlon Custom Fit KneePlacebo comparatorimplanted in standard fashion
Receives: Device: Stryker Triathlon Custom Fit Knee
Stryker shape matchExperimentalno longer RCT
Receives: Device: Stryker ShapeMatch Technology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted18 Apr 2017
  2. Study startFeb 2014
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Why it stopped: no longer RCT - same surgical technique and implant used

Resources

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)
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

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.

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