Porous Baseplate in Total Knee Replacement
- Conditions
- Knee Osteoarthritis
- Interventions
- Device: POROUS TIBIA BASEPLATE W/ JRNY LOCK
- Registration Number
- NCT05226689
- Lead Sponsor
- Canadian Radiostereometric Analysis Network
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 31
- Symptomatic osteoarthritis of the knee indicating primary unilateral total knee arthroplasty
- Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
- Aged 21 years or older
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
- Active or prior infection
- Medical condition precluding major surgery
- Known medical condition limiting patient life expectancy to < 2 years
- Expected to receive contralateral TKA within 1 year
- Inflammatory arthropathy
- Prior patellectomy
- PCL deficiency
- Major (>25 degree) coronal plane deformity
- Bilateral coronal plane deformity requiring simultaneous bilateral TKA
- Bone defects requiring augments, cones and/or stemmed implants
- Body Mass Index greater than 40
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description POROUS TIBIA BASEPLATE W/ JRNY LOCK POROUS TIBIA BASEPLATE W/ JRNY LOCK Fixed-bearing POROUS TIBIA BASEPLATE W/ JRNY LOCK and a Legion cruciate-retaining High-Flex or Deep-dish XLPE tibial insert.
- Primary Outcome Measures
Name Time Method Change between 6 months and 1-year post-operative - tibial baseplate stability 6 Months and 1 Year Maximum total point motion (MTPM) migration of the POROUS TIBIA BASEPLATE W/ JRNY LOCK between 6 months and 1 year post-operative (mm)
- Secondary Outcome Measures
Name Time Method Total MTPM migration of the baseplate at 1 year 1 Year Assessment of the stability of the tibial baseplate (mm)
Patient complications 6 Weeks, 6 Months, 1 Year and 2 Years Evaluate the type and frequency of the complications/adverse events.
Change between 1- and 2-years post-operative - tibial baseplate stability 1 Year and 2 Years Maximum total point motion (MTPM) migration of the POROUS TIBIA BASEPLATE W/ JRNY LOCK between 1 year and 2 years post-operative (mm)
Establish the post-operative migration pattern of the patellar and femoral components 6 Weeks and 6 Months Assessment of the migration pattern (mm)
Forgotten Joint Score (FJS) Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years 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.
University of California at Los Angeles (UCLA) Activity Level scale Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years 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.
Satisfaction VAS Preoperative, 6 Months, 1 Year and 2 Years 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)
European Quality of Life (EQ-5D-5L) Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years 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".
Patient-reported Outcome: Oxford Knee Score Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years 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.
Knee Injury and Osteoarthritis Outcomes Score (KOOS JR.) Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years 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).
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? 1 Year Assessment of the baseplate displacement differences between standing and supine RSA (mm)
Pain VAS Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years 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)
Trial Locations
- Locations (2)
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Concordia Hospital
🇨🇦Winnipeg, Manitoba, Canada