Improving knee replacement outcomes using a pressure sensor for alignment
Balancing Kinematically Aligned Total Knee Replacements During Total Primary Knee Arthroplasty Using Verasense
This study tests if using a special pressure sensor during knee replacement surgery can help people with osteoarthritis walk better and feel more satisfied with their results compared to standard surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT03286868 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of using the Verasense pressure sensor to optimize the alignment of total knee replacements (TKR) during surgery for patients with osteoarthritis. It involves a randomized controlled design where participants will either receive a kinematically aligned TKR with the guidance of the Verasense sensor or a standard TKR without sensor data. The primary focus is on assessing postoperative gait and patient satisfaction, while secondary outcomes include the number of soft tissue releases during surgery. The goal is to determine if sensor-guided alignment leads to better functional outcomes compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 80 with symptomatic knee arthritis requiring total knee arthroplasty and who have varus alignment.
Not a fit: Patients with inflammatory arthritis, severe obesity, or those unable to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to higher patient satisfaction and improved mobility after knee replacement surgery.
How similar studies have performed: Previous studies have shown promise in using sensor technology for surgical alignment, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptomatic arthritis 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 * Varus alignment Exclusion Criteria: * Patients less than 21 years of age, or 81 years of age and older * Unable to provide consent * BMI \>45 * Pregnancy * Patients with inflammatory arthritis, posttraumatic osteoarthritis, post high tibial osteotomy, or arthritis due to sepsis will be excluded. * Active or prior infection * Medical condition precluding major surgery * Severe osteoporosis or osteopenia * Neuromuscular impairment * Significant co-morbidity affecting ability to ambulate * Valgus alignment
Where this trial is running
Halifax, Nova Scotia
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Study coordinator: Research Manager
- Email: elise.laende@nshealth.ca
- Phone: 902-473-3883
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.