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| Name | Class |
|---|---|
| Orthopaedic Innovation Centre | OTHER |
| Dalhousie University | OTHER |
| London Health Sciences Centre | OTHER |
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The principal objective of this study is to compare migration patterns between the Attune and Attune S+ PS knee systems using model-based RSA over the first 2 post-operative years. Secondary objectives include; comparison of 2-year migration values against published thresholds for adequate short-term fixation, quantify changes in functional and health status of subjects following surgery and compare between study groups, and assess occurrences of complications following surgery.
This is a multi-centre, randomized controlled trial of patients undergoing posterior-stabilized total knee arthroplasty. In this study, the investigators propose to randomize 50 subjects to receive either the standard Attune PS TKA (n=25) or the enhanced fixation Attune S+ PS TKA (n=25) and follow them for a period of 2 years post-operatively. The primary outcome of the study will be stability of fixation of the tibial baseplate as measured by model-based RSA. Secondary outcomes will be to determine the functionality of patients after surgery using self-reported questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard implants | Active Comparator | ATTUNE PS Knee |
|
| Enhanced-Fixation | Active Comparator | ATTUNE S+ PS Knee |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATTUNE PS Knee | Device | The ATTUNE PS Knee is the standard implants. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| RSA Migration | Migration of the tibial and femoral components between the 2 device designs. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Replacement Expectation Survey (KRES) | The KRES is a patient reported questionnaire that consists of 19 questions. The questions ask how each expectation is important in the treatment of the knee. The scale is rated: 1 (Very important) to 5 (This does not apply to me). The score ranges from 19 to 95 with higher scores associated with higher expectations. | Preoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Turgeon, MD MPH FRCSC | University of Manitoba | Principal Investigator |
| Glen Richardson, MD MSc FRCSC | Dalhousie University | Principal Investigator |
| Douglas Naudie, MD FRCSC | London Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concordia Hospital | Winnipeg | Manitoba | R2K 3S8 | Canada | ||
| London Health Sciences Centre |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ATTUNE S+ PS Knee |
| Device |
The ATTUNE S+ PS Knee is the enhanced fixation. |
|
| European Quality of Life (EQ-5D-5L) | Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments. The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject. | Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years |
| Pain score | 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, 3 Months, 6 Months, 1 Year and 2 Years |
| Patient satisfaction | 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 |
| Oxford 12 Knee | Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments, patient reported outcome | Preoperative, 6 Weeks, 3 Months, 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 Months, 1 Year and 2 Years] |
| Pain Catastrophizing Scale (PCS) | The patient are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain. Each PCS item is rated on a 5-point scale: 0 (not at all) to 4 (all the time). The PCS total score is computed by summing responses to the 13 items. PCS total scores range from 0 - 52. | Preoperative and 1 Year |
| Pre-operative Patient's Knee Implant Performance (PKIP) | The Pre-surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient reported questionnaire that consists of 24 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likaert- like response option. | Preoperative, 6 Months, 1 Year and 2 Years |
| Patient complications | Evaluate the type and frequency of the complications/adverse events. | Preoperative, 1 Week, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years |
| London |
| Ontario |
| N6A 5W9 |
| Canada |
| D012216 |
| Rheumatic Diseases |