Osteo Arthritis Knee
Conditions
Brief summary
This is a multi-centre, single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System.
Detailed description
All patients will undergo post-operative radiostereometric analysis (RSA) and computed tomography (CT) to quantify and characterize the in vivo migration pattern of the Attune AFFIXIUM Cementless Tibial Baseplate and the Attune POROCOAT Cementless Femoral Component up to 24 months. 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.
Interventions
DEVICEAttune Cementless
* Attune AFFIXIUM Cementless Tibial Baseplate, Fixed Bearing * Attune POROCOAT Cementless Femoral Component, Cruciate Retaining * Attune AOX Antioxidant Polyethylene Tibial Insert, Cruciate Retaining * Attune AOX Patellar Button, Domed or Medialized Dome, Cemented or Cementless (surgeon preference for resurfacing)
Sponsors
Canadian Radiostereometric Analysis Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty * Patients aged 21 years or older * Sufficient ligamentous function to warrant retention of the posterior cruciate ligament * Patients willing and able to comply with follow-up requirements and self-evaluations * Ability to give informed consent
Exclusion criteria
* Active or prior infection of ipsilateral extremity * Medical condition precluding major surgery * Inflammatory arthropathy * Posterior cruciate ligament (PCL) deficiency * Major coronal plane deformity * Conditions that are cautioned against or contraindicated, as listed in the product monograph and/or instruction for use * Bone defects requiring augments, cones and/or stemmed implants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tibial baseplate stability | 6-12 months, 1-2 years post-operative | Maximum total point motion (MTPM) migration between 6-12 months and 1-2 year post-operative (mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tibial baseplate migration | Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years | To quantify and characterize tibial baseplate migration between weight-bearing and non-weight-bearing examinations at 24 months after surgery. |
| Equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration | Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years | To assess equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration for both tibial and femoral migration |
| 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. |
| 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. |
| Femoral component migration | Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years | To quantify and characterize femoral component migration up to 24 months after surgery |
| Satisfaction 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 pain severity as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied) |
| Patient complications | Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years | Evaluate the type and frequency of the complications/adverse events. |
| Linear depth (wear) on the tibial insert | Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years | To estimate linear depth (wear) on the tibial insert (experimental). |
| 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. |
Countries
Canada
Outcome results
None listed