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The purpose of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system using model-based RSA over the first 2 post-operative years.
This is a multi-centre, randomized controlled trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune S+ fixed bearing TKR system. Patients will be randomized to two study groups:
The principal objective of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system 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, comparison of functional and health status of subjects following surgery, comparison of intra-operative soft-tissue releases, incidence of complications and adverse events, and to assess several health economic parameters relating to the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neutral Mechanical Alignment | Active Comparator | Total knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment |
|
| Anatomical Alignment | Active Comparator | Total knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neutral Mechanical Alignment | Procedure | Hip-knee-ankle angle of 180° ± 3°. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Implant migration | Measured via radiosteriometric analysis (RSA) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford-12 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. | Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Turgeon | Concordia Joint Replacement Group | 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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Patients will be randomized to either Neutral mechanical alignment or Anatomical alignment using randomly generated numbers permuted in blocks of 4.
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The patient will not be informed of their study allocation.
| Anatomical Alignment |
| Procedure |
Restoring a patient's pre-diseased limb alignment |
|
| 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. | Pre-operative, 12 months |
| 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 generic health status - completed by the subject. The EQ5D uses a Likert scale which assesses five states (mobility, self care, usual care, pain and discomfort and anxiety and depression) at five different levels - none(0), slight(1), moderate(2), severe(3) or unable to perform(5). Levels are coded 1-5 and an index score is then generated. | Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years |
| 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. | Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years |
| 7. 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. | Pre-operative, 6 months, 1 year, 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, 3 Months, 6 Months, 1 Year, 2 Years |
| Patient 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, 3 Months, 6 Months, 1 Year, 2 Years |
| Patient complications | Evaluate the type and frequency of the complications/adverse events. | Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year, 2 Years |
| Hospital stay | Number of days in hospital | Up to 1 week |
| Tourniquet time | Length of time tourniquet was applied (minutes) | Intraoperative |
| Length of surgery | Length of surgery, from open to closing of incision (minutes) | Intraoperative |
| Blood loss | Amount of blood loss during the procedure (mL) | Intraoperative |
| Anesthesia type | Anesthesia methods (general, spinal, epidural, TXA) | Intraoperative |
| Peri-operative pain management | A tabulation of the pain management (Peri-Articular Injection, Femoral Nerve Block, Add. Canal Block or none) used during the procedure. | Intraoperative |
| Soft tissue release | A tabulation of the tissue released during the procedure (MCL, LCL, PCL, Posterior Capsule Release). | Intraoperative |
| London |
| Ontario |
| N6A 5W9 |
| Canada |
| D012216 |
| Rheumatic Diseases |