Study Stopped
no longer RCT - same surgical technique and implant used
TKA Using Patient-Specific Instrumentation
A Randomized Control Trial Comparing an Anatomical Axis Aligned and Conventional Mechanical Axis Total Knee Arthroplasty Using Patient-Specific Instrumentation
2 other identifiers
interventional
N/A
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedApril 6, 2018
April 1, 2018
1 year
April 7, 2014
April 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
gait analysis
Treadmill walk
12 months
Study Arms (2)
Stryker Triathlon Custom Fit Knee
PLACEBO COMPARATORimplanted in standard fashion
Stryker shape match
EXPERIMENTALno longer RCT
Interventions
Will use this patient-specific guide for alignment with Stryker Triathlon Custom Fit Knee.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- below age 50 and/or above age 75
- BMI less than 20 or greater than 40
- ASA of 3 or higher
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gavin Wood, MD
Queen's University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 7, 2014
First Posted
April 18, 2017
Study Start
February 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
April 6, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share