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Roentgen Stereophotogrammetric Analysis (RSA) and Dual Energy X-ray Absorptiometry (DEXA) to Evaluate Fixation of Periapatite Coated Triathlon Total Knee Arthroplasty (TKA) Components

This study has been completed.
Stryker Orthopaedics
Nova Scotia Health Authority
Information provided by (Responsible Party):
Michael Dunbar, Dalhousie University Identifier:
First received: August 11, 2010
Last updated: March 28, 2014
Last verified: March 2014

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?

Condition Intervention
Osteoarthritis, Knee Device: Triathlon Periapatite (PA)-coated Tibial Component

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Clinical Study Using Roentgen Stereophotogrammetric Analysis (RSA) and DEXA to Evaluate Fixation of Periapatite Coated Triathlon Total Knee Arthroplasty Components

Resource links provided by NLM:

Further study details as provided by Michael Dunbar, Dalhousie University:

Primary Outcome Measures:
  • Migration of tibial component as measured with RSA [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Bone mineral density [ Time Frame: 2 years ]
  • Subjective health outcome questionnaires - SF-36, WOMAC, Knee Society Function Score, Pain Catastrophizing Scale (PCS), Self-Administered Comorbidity Questionnaire (SCQ) [ Time Frame: 2 years ]

Enrollment: 30
Study Start Date: April 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Triathlon Periapatite (PA)-coated Tibial Component
    Triathlon Periapatite (PA)-coated Total Knee Arthroplasty Tibial Component for uncemented fixation

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • symptomatic osteoarthritis of the knee indicating surgical intervention
  • ability to give informed consent

Exclusion Criteria:

  • significant co-morbidity affecting ability to ambulate
  • range of motion measurements that are beyond the realm of normal
  • a BMI > 40 (morbid obesity)
  • severe osteoporosis or osteopenia or neuromuscular impairment
  • women who are pregnant will also be excluded due to the risks of the surgery
  Contacts and Locations
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Please refer to this study by its identifier: NCT01180582

Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Dalhousie University
Stryker Orthopaedics
Nova Scotia Health Authority
Principal Investigator: Michael J Dunbar, FRCSC, PhD Dalhousie University & Capital District Health Authority
  More Information

Responsible Party: Michael Dunbar, MD, PhD, Dalhousie University Identifier: NCT01180582     History of Changes
Other Study ID Numbers: CDHA-RS/2009-039
Study First Received: August 11, 2010
Last Updated: March 28, 2014

Keywords provided by Michael Dunbar, Dalhousie University:

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on September 21, 2017