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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System | Other | Attune Cruciate Retaining TKA System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attune Cementless | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tibial baseplate stability | Maximum total point motion (MTPM) migration between 6-12 months and 1-2 year post-operative (mm) | 6-12 months, 1-2 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Femoral component migration | To quantify and characterize femoral component migration up to 24 months after surgery | Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years |
| Tibial baseplate migration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Turgeon, MD | Concordia Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Innovation Centre | Winnipeg | Manitoba | R2K 2M9 | Canada | ||
| Nova Scotia Health - Orthopedic |
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To quantify and characterize tibial baseplate migration between weight-bearing and non-weight-bearing examinations at 24 months after surgery.
| Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years |
| Equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration | To assess equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration for both tibial and femoral migration | Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years |
| 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 |
| 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 |
| 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 Weeks, 6 Months, 1 Year and 2 Years |
| Patient complications | Evaluate the type and frequency of the complications/adverse events. | Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years |
| Linear depth (wear) on the tibial insert | To estimate linear depth (wear) on the tibial insert (experimental). | Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years |
| Halifax |
| Nova Scotia |
| B3H 2E1 |
| Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |