Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement
- Conditions
- Osteo Arthritis Knee
- Interventions
- Device: Attune Cementless
- Registration Number
- NCT06189872
- Lead Sponsor
- Canadian Radiostereometric Analysis Network
- Brief Summary
This is a multi-centre, single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System.
- Detailed Description
All patients will undergo post-operative radiostereometric analysis (RSA) and computed tomography (CT) to quantify and characterize the in vivo migration pattern of the Attune AFFIXIUM Cementless Tibial Baseplate and the Attune POROCOAT Cementless Femoral Component up to 24 months. Patient health and functional outcomes will be recorded at pre- and post-operative intervals for all patients. Peri-operative adverse events and other clinical complications will be captured as encountered.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
- Patients aged 21 years or older
- Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
- Active or prior infection of ipsilateral extremity
- Medical condition precluding major surgery
- Inflammatory arthropathy
- Posterior cruciate ligament (PCL) deficiency
- Major coronal plane deformity
- Conditions that are cautioned against or contraindicated, as listed in the product monograph and/or instruction for use
- Bone defects requiring augments, cones and/or stemmed implants
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System Attune Cementless Attune Cruciate Retaining TKA System
- Primary Outcome Measures
Name Time Method Tibial baseplate stability 6-12 months, 1-2 years post-operative Maximum total point motion (MTPM) migration between 6-12 months and 1-2 year post-operative (mm)
- Secondary Outcome Measures
Name Time Method Linear depth (wear) on the tibial insert Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years To estimate linear depth (wear) on the tibial insert (experimental).
Femoral component migration Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years To quantify and characterize femoral component migration up to 24 months after surgery
Oxford Knee Score Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years 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.
Satisfaction VAS Preoperative, 6 Weeks, 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)
Patient complications Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years Evaluate the type and frequency of the complications/adverse events.
Equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years To assess equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration for both tibial and femoral migration
European Quality of Life (EQ-5D-5L) Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years EQ5D consists of 5 subscales; Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety / depression. A health state score is obtained based on the responses from 1-5 in each subscale, from which a single index value is calculated representing patients' overall health state. EQ5D includes a so called EQ VAS score which is the patients' self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled "the best health you can imagine" and "the worst health you can imagine".
Tibial baseplate migration Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years To quantify and characterize tibial baseplate migration between weight-bearing and non-weight-bearing examinations at 24 months after surgery.
Forgotten Joint Score (FJS) Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years The FJS total score range is 0-100, higher scores indicating the patient is able to forget the joint daily or lower degree of joint awareness.
Trial Locations
- Locations (3)
Orthopaedic Innovation Centre
🇨🇦Winnipeg, Manitoba, Canada
Nova Scotia Health - Orthopedic
🇨🇦Halifax, Nova Scotia, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada