RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard implants ATTUNE PS Knee |
Device: ATTUNE PS Knee
The ATTUNE PS Knee is the standard implants.
|
| Active Comparator: Enhanced-Fixation ATTUNE S+ PS Knee |
Device: ATTUNE S+ PS Knee
The ATTUNE S+ PS Knee is the enhanced fixation.
|
Outcome Measures
Primary Outcome Measures
- RSA Migration [2 Years]
Migration of the tibial and femoral components between the 2 device designs.
Secondary Outcome Measures
- 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.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Concordia Hospital | Winnipeg | Manitoba | Canada | R2K 3S8 |
| 2 | London Health Sciences Centre | London | Ontario | Canada | N6A 5W9 |
Sponsors and Collaborators
- Canadian Radiostereometric Analysis Network
- Orthopaedic Innovation Centre
- Dalhousie University
- London Health Sciences Centre
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS21601