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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating total knee replacement (TKR) surgery to address pain and decreased function caused by severe knee arthritis. This study focuses on comparing two surgical approaches: the traditional mechanical alignment, which straightens the leg bones, and a newer kinematic alignment that respects the patient's natural leg alignment. The study also investigates how using an intraoperative pressure sensor called Verasense to measure soft tissue balance during surgery may affect patient outcomes and satisfaction. Participants will undergo kinematically aligned TKR and be randomly assigned to one of two groups. One group will have their surgery balanced using standard surgeon judgment without access to Verasense data, while the other group will have surgery guided by real-time Verasense pressure sensor feedback to optimize knee balance. The study uses computer-assisted techniques and aims to assess differences in soft tissue balance and the number of ligament releases required during surgery. During the study, participants will be followed for up to two years with assessments including gait analysis to evaluate knee function and patient-reported health outcome questionnaires. Researchers will monitor intraoperative ligament releases and analyze postoperative knee kinematics. The study aims to determine if objective balancing with Verasense improves surgical outcomes compared to the standard subjective method, with safety and function tracked throughout the follow-up period.
CONDITIONS
Brief 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 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
- Active or prior infection
- Medical condition precluding major surgery
- Severe osteoporosis or osteopenia
- Neuromuscular impairment
- Significant co-morbidity affecting ability to ambulate
- Valgus alignment
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery day and hospital stay period
Participants undergo total knee arthroplasty either with standard surgical balancing or with the use of the Verasense pressure sensor to optimize implant pressures during surgery.
1 surgery visit (in-person) and immediate post-operative care
Duration - Up to 2 years
Participants are monitored post-surgery for recovery and undergo gait assessments and patient reported outcome measures to evaluate soft tissue balance and function.
Multiple follow-up visits for assessments over 2 years
Trial Site Locations
Total: 1 location
1
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Actively Recruiting
Research Team
R
Research Manager
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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