Status:
RECRUITING
Balancing Kinematically Aligned Total Knee Replacements During Total Primary Knee Arthroplasty Using Verasense
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
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 reli...
Detailed Description
The primary objective of this research study is to evaluate the use of the Verasense pressure sensor to optimize intraoperative implant pressures/balance during computer assisted TKR utilizing pre- an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03286868
Start Date
July 23 2018
End Date
September 1 2026
Last Update
February 17 2025
Active Locations (1)
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1
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7