Knee Osteoarthritis
Conditions
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.
Interventions
DEVICEATTUNE PS Knee
The ATTUNE PS Knee is the standard implants.
DEVICEATTUNE S+ PS Knee
The ATTUNE S+ PS Knee is the enhanced fixation.
Sponsors
Orthopaedic Innovation Centre
Dalhousie University
London Health Sciences Centre
Canadian Radiostereometric Analysis Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RSA Migration | 2 Years | Migration of the tibial and femoral components between the 2 device designs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed