This is a multi-centre single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Advance Porous fixed bearing tibial baseplate and compatible femoral, patellar, and bearing components.
All patients will undergo post-operative model-based RSA to identify migration of the tibial baseplate with respect to the bone as well as migration of the patellar and femoral components with respect to the bone during the first 2 post-operative years. Patient health and functional outcomes will be recorded at pre- and post-operative intervals for all patients. Peri-operative adverse events and other clinical complications will be captured as encountered.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Fixed-bearing POROUS TIBIA BASEPLATE W/ JRNY LOCK and a Legion cruciate-retaining High-Flex or Deep-dish XLPE tibial insert
Concordia Hospital
Winnipeg, Manitoba, Canada
London Health Sciences Centre
London, Ontario, Canada
Change between 6 months and 1-year post-operative - tibial baseplate stability
Maximum total point motion (MTPM) migration of the POROUS TIBIA BASEPLATE W/ JRNY LOCK between 6 months and 1 year post-operative (mm)
Time frame: 6 Months and 1 Year
Change between 1- and 2-years post-operative - tibial baseplate stability
Maximum total point motion (MTPM) migration of the POROUS TIBIA BASEPLATE W/ JRNY LOCK between 1 year and 2 years post-operative (mm)
Time frame: 1 Year and 2 Years
Total MTPM migration of the baseplate at 1 year
Assessment of the stability of the tibial baseplate (mm)
Time frame: 1 Year
Establish the post-operative migration pattern of the patellar and femoral components
Assessment of the migration pattern (mm)
Time frame: 6 Weeks and 6 Months
What is the magnitude of baseplate displacement that results from patient weight-bearing (single leg stance) versus non-weight-bearing at 1-year post-operation?
Assessment of the baseplate displacement differences between standing and supine RSA (mm)
Time frame: 1 Year
European Quality of Life (EQ-5D-5L)
EQ5D consists of 5 subscales; Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety / depression. A health state score is obtained based on the responses from 1-5 in each subscale, from which a single index value is calculated representing patients' overall health state. EQ5D includes a so called EQ VAS score which is the patients' self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled "the best health you can imagine" and "the worst health you can imagine".
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Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Patient-reported Outcome: Oxford Knee Score
The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OKS measures pain and general activities of daily living.
Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Forgotten Joint Score (FJS)
The FJS total score range is 0-100, higher scores indicating the patient is able to forget the joint daily or lower degree of joint awareness.
Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Knee Injury and Osteoarthritis Outcomes Score (KOOS JR.)
The KOOS JR. was a participant completed questionnaire that consists of 7 questions from 3 subscales: stiffness (1 question), pain (4 questions), and function in daily living (2 questions). Standardized answer options are given (5 Likert boxes) and each question was assigned a score from none (0) to extreme (4).
Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
University of California at Los Angeles (UCLA) Activity Level scale
Evaluate and compare the change in UCLA activity score compared to baseline in the study cohort. UCLA activity scores range from 1 to 10, and is a measure of activity with 10 being most active.
Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Pain VAS
Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable)
Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Satisfaction VAS
Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported pain severity as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied)
Time frame: Preoperative, 6 Months, 1 Year and 2 Years
Patient complications
Evaluate the type and frequency of the complications/adverse events.
Time frame: 6 Weeks, 6 Months, 1 Year and 2 Years