Roentgen Stereophotogrammetric Analysis (RSA) and Dual Energy X-ray Absorptiometry (DEXA) to Evaluate Fixation of Periapatite Coated Triathlon Total Knee Arthroplasty (TKA) Components
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ClinicalTrials.gov Identifier: NCT01180582 |
Recruitment Status :
Completed
First Posted : August 12, 2010
Last Update Posted : March 31, 2014
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis, Knee | Device: Triathlon Periapatite (PA)-coated Tibial Component | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | N/A |
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 |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |

- Device: Triathlon Periapatite (PA)-coated Tibial Component
Triathlon Periapatite (PA)-coated Total Knee Arthroplasty Tibial Component for uncemented fixation
- Migration of tibial component as measured with RSA [ Time Frame: 2 years ]
- 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 ]

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Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180582
Canada, Nova Scotia | |
QEII Health Sciences Centre | |
Halifax, Nova Scotia, Canada, B3H 3A7 |
Principal Investigator: | Michael J Dunbar, FRCSC, PhD | Dalhousie University & Capital District Health Authority |
Responsible Party: | Michael Dunbar, MD, PhD, Dalhousie University |
ClinicalTrials.gov Identifier: | NCT01180582 |
Other Study ID Numbers: |
CDHA-RS/2009-039 |
First Posted: | August 12, 2010 Key Record Dates |
Last Update Posted: | March 31, 2014 |
Last Verified: | March 2014 |
knee arthroplasty RSA |
migration micromotion osteoarthritis |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |