Knee Arthroplasty, Total, Knee Osteoarthritis, Radiostereometric Analysis
Conditions
Keywords
Osteoarthritis, Cementless Fixation, Gut Microbiome, Weight-Bearing Computed Tomography
Brief summary
All artificial joint implants need to be solidly held (fixed) within the bone. Cementless fixation has become a popular method to achieve fixation for total knee replacements where the bone grows directly onto the implanted device instead of using bone cement. The primary purpose of this study is to assess long-term implant survivorship and clinical outcomes of a previous study cohort that received a cementless knee replacement. As this study cohort approaches 5 years post-operation, the investigators will re-examine the stability of participant implants using specialized x-rays, called radiostereometric analysis. The study will use weight-bearing computed tomography (CT) to measure bone density and texture features and correlate that with implant stability. The investigators will collect stool samples to assess participant gut microbiomes for biomarkers of poor bone quality that could correlate to implant stability. All 33 participants from the original study cohort will be invited to participate in this study.
Interventions
Artificial knee implant inserted by cementless fixation.
Sponsors
Schulich School of Medicine and Dentistry
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Were in the originally investigated cohort * Had successful imaging at 1-year post-operation * Minimum of 5 years post-operation
Exclusion criteria
* Pregnancy * Unable to follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Migration (tibial component) | 5 year follow-up | Implant movement will be measured with model-based Radiostereometric Analysis (RSA) by registering the location of the tibial component during supine exams. Potential tibial component migration between 1 and 5 years post-operation will be measured in millimeters with the use of tibial bone markers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inducible Displacement (RSA-based) | 5 year follow-up | Model-based Radiostereometric Analysis (RSA) will be used to register the location of the tibial and femoral components during supine and standing exams. Change in implant position will be measured in millimeters as maximum total point motion (MTPM) between the standing and supine RSA exams. |
| Inducible Displacement (CT-based) | 5 year follow-up | Weight-bearing computed tomography (CT) will be used to register the location of the tibial and femoral components during seated and standing exams. Change in implant position will be measured in millimeters as maximum total point motion (MTPM) between the seated and standing CT exams. |
| Bone Density | 5 year follow-up | Weight-bearing computed tomography (CT) scans will be used to measure bone density as Hounsfield units in standardized volumes of interest below the pegs and keel of the tibial component. |
| Texture Features | 5 year follow-up | Weight-bearing computed tomography (CT) texture analysis will be performed in standardized volumes of interest below the pegs and keel of the tibial component. |
| Microbial Diversity | 5 year follow-up | Participants will provide a stool sample. Microbial DNA will be extracted from the stool samples for 16s rRNA sequencing. Taxonomy will be assigned and functional annotation will be determined. |
| Implant Migration (femoral component) | 5 year follow-up | Implant movement will be measured with model-based Radiostereometric Analysis (RSA) by registering the location of the femoral component during supine exams. Potential femoral component migration between 1 and 5 years post-operation will be measured in millimeters with the use of femoral bone markers. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score (KSS) | 5 year follow-up | Patient reported outcome measure. Contains 5 sections measuring patient symptoms (none to severe), satisfaction (very satisfied to very dissatisfied), expectation (too high to too low), functional activities, and discretionary knee activities. Functional activities are split into walking and standing (with or without aids and the duration), standard activities (no bother to cannot do), and advanced activities (no bother to cannot do). Discretionary knee activities measure difficulty with the three most important activities for the patient (no bother to cannot do). Higher scores indicate greater patient outcomes. |
| UCLA Activity Score | 5 year follow-up | Patient reported outcome measure observing activity level of patient. Contains a 10-level scale with 1 representing a patient who is inactive and dependent on others, to 10 representing a patient who regularly participates in impact sports. A higher score indicates a greater activity level. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 5 year follow-up | Patient reported outcome measure observing physical symptoms following recent knee replacement surgery. Contains 24 questions asking about the amount of pain, stiffness, and activity difficulty (none to extreme). A higher score indicates greater pain, stiffness, and activity difficulty. |
| 12-Item Short Form Survey (SF-12) | 5 year follow-up | Patient reported outcome measure observing physical and mental health status of patient. There are 12 questions asking about health (excellent to poor), activity limitations (yes, limited a lot to no, not limited at all), problems with daily activities from physical or emotional health (yes or no), pain interfering with normal work (not at all to extremely), recent positive or negative feelings (all of the time to none of the time), and interference of physical or emotional problems with social activities (all of the time to none of the time). A higher score indicates better physical and mental health function. |
Countries
Canada
Outcome results
None listed