Actively Recruiting

Phase Not Applicable
Age: 21Years - 80Years
All Genders
ID03286868

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

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

Loading map...

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

Similar Trials

Adipose-Derived Biocellular Regenerative Therapy in Treatmen...

Osteoarthritis

Actively Recruiting

2 locations

An Open Label Phase IIb Study to Evaluate Safety and Tolerab...

Osteoarthritis

Actively Recruiting

1 location

A Randomised Control Trial of an Intraarticular Hydrogel Art...

Osteo Arthritis Knee

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here