Analysis of knee replacement migration patterns using Attune system
Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement: A Multi-Center, Non-Controlled, Prospective Study
NA · Canadian Radiostereometric Analysis Network · NCT06189872
This study is testing how well the Attune knee replacement system stays in place and how it affects patients' recovery over two years.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Canadian Radiostereometric Analysis Network (other) |
| Locations | 3 sites (Winnipeg, Manitoba and 2 other locations) |
| Trial ID | NCT06189872 on ClinicalTrials.gov |
What this trial studies
This multi-centre trial focuses on patients undergoing total knee arthroplasty with the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System. Participants will undergo post-operative radiostereometric analysis and CT scans to assess the migration patterns of the knee components over a period of 24 months. Additionally, patient health and functional outcomes will be monitored at various intervals, and any peri-operative complications will be documented. The study aims to provide insights into the performance and stability of the knee replacement system.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with symptomatic osteoarthritis of the knee requiring total knee arthroplasty.
Not a fit: Patients with active infections, major deformities, or conditions contraindicated for the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of knee replacement stability and improve surgical outcomes for patients with osteoarthritis.
How similar studies have performed: Previous studies using radiostereometric analysis have shown promise in evaluating joint replacements, suggesting this approach may yield valuable data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Winnipeg, Manitoba and 2 other locations
- Orthopaedic Innovation Centre — Winnipeg, Manitoba, Canada (RECRUITING)
- Nova Scotia Health - Orthopedic — Halifax, Nova Scotia, Canada (NOT_YET_RECRUITING)
- London Health Sciences Centre — London, Ontario, Canada (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Thomas Turgeon, MD — Concordia Hospital
- Study coordinator: Sarah Tran
- Email: stran@orthoinno.com
- Phone: 204-926-1231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteo Arthritis Knee