RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs
- Conditions
- Knee Osteoarthritis
- Registration Number
- NCT03554720
- Lead Sponsor
- Canadian Radiostereometric Analysis Network
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- Active or prior infection
- Medical condition precluding major surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method RSA Migration 2 Years Migration of the tibial and femoral components between the 2 device designs.
- Secondary Outcome Measures
Name Time Method European Quality of Life (EQ-5D-5L) Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years 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.
Pain score Preoperative, 6 Weeks, 3 Months, 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 satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable)
Patient satisfaction Preoperative, 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)
Oxford 12 Knee Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments, patient reported outcome
University of California at Los Angeles (UCLA) Activity Level scale Preoperative, 6 Months, 1 Year and 2 Years] 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 Patient's Knee Implant Performance (PKIP) Preoperative, 6 Months, 1 Year and 2 Years 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.
Knee Replacement Expectation Survey (KRES) Preoperative 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.
Pain Catastrophizing Scale (PCS) Preoperative and 1 Year 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.
Patient complications Preoperative, 1 Week, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years Evaluate the type and frequency of the complications/adverse events.
Trial Locations
- Locations (2)
Concordia Hospital
🇨🇦Winnipeg, Manitoba, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Concordia Hospital🇨🇦Winnipeg, Manitoba, Canada