Actively Recruiting
Balancing Kinematically Aligned Total Knee Replacements During Total Primary Knee Arthroplasty Using Verasense
Led by Nova Scotia Health Authority · Updated on 2025-02-17
60
Participants Needed
1
Research Sites
423 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Total Knee Replacement (TKR) is an operation to help with the pain and decreased function that happens with end stage arthritis of the knee. This operation has been shown to be very successful at relieving pain and improving patient mobility; however, some studies have shown that up to 20% of TKR recipients are not happy with their knee replacement. All of the reasons why some patients are not pleased with the outcome of surgery are not known, but one of the possible causes is the way the implants are placed, or aligned, during surgery. Most TKRs are aligned in a fashion that the bones in the leg are completely straight after surgery. This is known as mechanically aligning a TKR. A different alignment method known as kinematic alignment respects the natural bow legged or knock kneed alignment of the patient. It is hoped that kinematically aligning a knee replacement will improve how the knee feels to the patient and therefore improve their satisfaction. Another potential factor affecting the outcomes of TKR is obtaining optimal soft tissue balance. The challenge with balancing a TKR is that traditional operative techniques rely on subjective feel of the knee stability during surgery. The balance or tension in the knee can however be objectively measured using specialized intraoperative pressure sensing devices. The purpose of this study is to assess the impact of kinematically aligned TKR on the pressures measured by Verasense during total knee replacements. The study will also determine if differences in the pressure measured during TKR surgery impact patient outcomes after surgery.
CONDITIONS
Official Title
Balancing Kinematically Aligned Total Knee Replacements During Total Primary Knee Arthroplasty Using Verasense
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients younger than 21 years or older than 80 years
- Unable to provide informed consent
- Body mass index (BMI) over 45
- Pregnancy
- Inflammatory arthritis, posttraumatic osteoarthritis, post high tibial osteotomy, or arthritis due to sepsis
- Active or prior infection
- Medical conditions preventing major surgery
- Severe osteoporosis or osteopenia
- Neuromuscular impairment
- Significant co-morbidity affecting ability to walk
- Valgus alignment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Actively Recruiting
Research Team
R
Research Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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