Osteoarthritis, Knee Clinical Trial
Official title:
Prospective Clinical Study Using Roentgen Stereophotogrammetric Analysis (RSA) and DEXA to Evaluate Fixation of Periapatite Coated Triathlon Total Knee Arthroplasty Components
The purpose of this study is twofold: 1) to use RSA to determine the migration patterns of
the PA coated Triathlon Total Knee Arthroplasty components during the first 2 years
postoperatively and thus determine the proportion of cases where adequate fixation is
achieved, and 2) to use DEXA scanning to document peri-prosthetic bone mineral density
changes in response to the PA coated Triathlon Total Knee arthroplasty over the first two
postoperative years.
In addition, gait assessment and validated outcome questionnaires will be utilized to
quantify changes in functional status of subjects after surgery and migration patterns will
be compared to results obtained from previous studies of uncemented total knee arthroplasty
components conducted at this centre. Questions to be asked are: 1. Do the components achieve
adequate fixation to the underlying bone? 2. What are the migration patterns (translations
and rotations) of the PA coated arthroplasty components during the first two years
postoperatively and are they different from that seen for other implants that have been
studied with RSA at this institution? 3. For what proportion of implants does migration
continue to increase during the two year follow-up? 4. Are inducible displacements, measured
at weight-bearing follow-ups, consistent over time and do they indicate that adequate
fixation has been achieved? 5. Are there changes over time in bone mineral density of
peri-prosthetic bone in the PA coated Triathlon total knee arthroplasty? 6: Where do changes
in bone mineral density occur? 7: Is there a significant difference in health status and
functional outcome before and after total knee arthroplasty using PA coated Triathlon total
knee arthroplasty components? 8: Are there changes in gait symmetry and centre of mass (COM)
displacements as assessed with the Walkabout Portable Gait Monitor pre- and post-operatively
and how does study gait data compare to asymptomatic gait? and finally, Question 9: Are
there differences in the micromotion patterns between the when compared to other samples of
knee implants in our RSA database?
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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