Balancing Kinematically Aligned Total Knee Replacements During Total Primary Knee Arthroplasty Using Verasense

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorNova Scotia Health Authority

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients less than 21 years of age, or 81 years of age and older

Unable to provide consent

BMI >45

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total Knee Arthroplasty

    Procedure/Surgery

    Total Knee Arthroplasty

  • Total Knee Arthroplasty with Verasense sensor

    Device

    Total Knee Arthroplasty with Verasense sensor

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Standard of Care TKAPlacebo comparator 1 intervention
Group B: TKA with Verasense sensorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

gait assessment

kinematic gait assessment using KneeKG

Time frame
2 years

Secondary outcomes

1

EQ-5D patient reported outcome measure

Health status measure

Time frame
2 years
2

Ligament releases

Number of ligament releases required during knee replacement

Time frame
Intra-operative

Other outcomes

Sponsors and contacts

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