RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Traditional Versus Enhanced-Fixation Device Designs

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: ATTUNE PS Knee
* Device: ATTUNE S+ PS Knee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty Between the ages of 21 and 80 inclusive 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard implants<br>ATTUNE PS Knee | Device: ATTUNE PS Knee<br>* The ATTUNE PS Knee is the standard implants.<br>|
| Active Comparator: Enhanced-Fixation<br>ATTUNE S+ PS Knee | Device: ATTUNE S+ PS Knee<br>* The ATTUNE S+ PS Knee is the enhanced fixation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RSA Migration | Migration of the tibial and femoral components between the 2 device designs. | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |