- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03117959
TKA Using Patient-Specific Instrumentation
April 4, 2018 updated by: Dr. Gavin Wood, Queen's University
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 5G2
- Hotel Dieu Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
48 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- below age 50 and/or above age 75
- BMI less than 20 or greater than 40
- ASA of 3 or higher
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Stryker Triathlon Custom Fit Knee
implanted in standard fashion
|
|
Experimental: Stryker shape match
no longer RCT
|
Will use this patient-specific guide for alignment with Stryker Triathlon Custom Fit Knee.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gait analysis
Time Frame: 12 months
|
Treadmill walk
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gavin Wood, MD, Queen's University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
April 7, 2014
First Submitted That Met QC Criteria
April 12, 2017
First Posted (Actual)
April 18, 2017
Study Record Updates
Last Update Posted (Actual)
April 6, 2018
Last Update Submitted That Met QC Criteria
April 4, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SURG-290-14
- 6011807 (Other Identifier: Queen's University TRAQ system)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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