Porous Baseplate in Total Knee Replacement

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Multicenter, RSA Study of the Porous Tibia Baseplate W/Jrny Lock

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: POROUS TIBIA BASEPLATE W/ JRNY LOCK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: POROUS TIBIA BASEPLATE W/ JRNY LOCK<br>Fixed-bearing POROUS TIBIA BASEPLATE W/ JRNY LOCK and a Legion cruciate-retaining High-Flex or Deep-dish XLPE tibial insert. | Device: POROUS TIBIA BASEPLATE W/ JRNY LOCK<br>* Fixed-bearing POROUS TIBIA BASEPLATE W/ JRNY LOCK and a Legion cruciate-retaining High-Flex or Deep-dish XLPE tibial insert<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 Months and 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 1 Year and 2 Years | 
| Total MTPM migration of the baseplate at 1 year | Assessment of the stability of the tibial baseplate (mm) | 1 Year | 
| Establish the post-operative migration pattern of the patellar and femoral components | Assessment of the migration pattern (mm) | 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) | 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. | 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. | 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. | 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). | 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. | 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) | 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) | Preoperative, 6 Months, 1 Year and 2 Years | 
| Patient complications | Evaluate the type and frequency of the complications/adverse events. | 6 Weeks, 6 Months, 1 Year and 2 Years |