Roentgen Stereophotogrammetric Analysis (RSA) and Dual Energy X-ray Absorptiometry (DEXA) to Evaluate Fixation of Periapatite Coated Triathlon Total Knee Arthroplasty (TKA) Components
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Triathlon Periapatite (PA)-coated Tibial Component
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring knee, arthroplasty, RSA, migration, micromotion, osteoarthritis
Eligibility Criteria
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
Sites / Locations
- QEII Health Sciences Centre
Outcomes
Primary Outcome Measures
Migration of tibial component as measured with RSA
Secondary Outcome Measures
Bone mineral density
Subjective health outcome questionnaires - SF-36, WOMAC, Knee Society Function Score, Pain Catastrophizing Scale (PCS), Self-Administered Comorbidity Questionnaire (SCQ)
Full Information
NCT ID
NCT01180582
First Posted
August 11, 2010
Last Updated
March 28, 2014
Sponsor
Dalhousie University
Collaborators
Stryker Orthopaedics, Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT01180582
Brief Title
Roentgen Stereophotogrammetric Analysis (RSA) and Dual Energy X-ray Absorptiometry (DEXA) to Evaluate Fixation of Periapatite Coated Triathlon Total Knee Arthroplasty (TKA) Components
Official Title
Prospective Clinical Study Using Roentgen Stereophotogrammetric Analysis (RSA) and DEXA to Evaluate Fixation of Periapatite Coated Triathlon Total Knee Arthroplasty Components
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dalhousie University
Collaborators
Stryker Orthopaedics, Nova Scotia Health Authority
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
knee, arthroplasty, RSA, migration, micromotion, osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Triathlon Periapatite (PA)-coated Tibial Component
Intervention Description
Triathlon Periapatite (PA)-coated Total Knee Arthroplasty Tibial Component for uncemented fixation
Primary Outcome Measure Information:
Title
Migration of tibial component as measured with RSA
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Bone mineral density
Time Frame
2 years
Title
Subjective health outcome questionnaires - SF-36, WOMAC, Knee Society Function Score, Pain Catastrophizing Scale (PCS), Self-Administered Comorbidity Questionnaire (SCQ)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Dunbar, FRCSC, PhD
Organizational Affiliation
Dalhousie University & Capital District Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Roentgen Stereophotogrammetric Analysis (RSA) and Dual Energy X-ray Absorptiometry (DEXA) to Evaluate Fixation of Periapatite Coated Triathlon Total Knee Arthroplasty (TKA) Components
We'll reach out to this number within 24 hrs