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

February 14, 2025 updated by: Nova Scotia Health Authority

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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- and postoperative kinematic alignment techniques.

This is a randomized controlled trial where 60 patients will undergo a kinematically aligned TKR using VERASENSE pressure sensors. Patients will be randomly assigned to either TKR balancing using VERASENSE data (TKR-V), or TKR using standard surgeon decision making in balancing (TKR only). In the TKR only group, the surgeon will perform the surgery while blinded to the data output of the VERASENSE sensor and will use standard surgeon decision making to balance the TKR. In the second group, TKR-V, the surgeon will not be blinded to the data output of the VERASENSE sensor and will use the data to influence how they balance the TKR.

The primary outcome measure will be postoperative kinematic gait assessment to evaluate the effect of optimizing patient soft tissue balance using Verasense pressure sensor. Secondary outcomes will include the number of intraoperative soft tissue releases, and results of health outcome questionnaires.

Research Questions:

  1. What are the differences and similarities between the subjective surgeon-balanced group (standard of care) compared to the objective Verasense-balanced group?
  2. Is there a difference in the number of "poorly balanced" knees between the surgeon-balanced kinematically aligned groups compared to the Verasense-balanced kinematically aligned group?
  3. Is there an effect of preoperative alignment on ligament balancing using Verasense pressure sensor?
  4. Is there a difference in the number of ligament releases required to optimize soft tissue balance between the Verasense pressure sensor aided total knee replacements and those balanced by the surgeon alone?
  5. What is the effect of optimizing patient soft tissue balance with Verasenes pressure sensor on gait parameters measured with Knee KG?

ANOVA will be used to examine pre and post-operative differences in specific features of knee kinematics between groups. Primary and secondary outcomes will be evaluated using listings and summary statistics. Improvement in pain and function will be analyzed using t-test or Wilcoxon Rank tests.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Recruiting
        • Nova Scotia Health Authority
        • Contact:
          • Elise Laende
          • Phone Number: 902-473-3883
        • Principal Investigator:
          • Michael Dunbar
        • Sub-Investigator:
          • Glen Richardson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Standard of Care TKA
Standard of Care Total Knee Arthroplasty (TKA): No data from the Verasense sensor will be used to influence the surgery
Procedure: Total Knee Arthroplasty
Total Knee Arthroplasty
Experimental: TKA with Verasense sensor
Total Knee Arthroplasty (TKA) with Verasense sensor for Intraoperative Balancing: Surgeon will attempt to optimize the intraoperative pressures using the data from the Verasense sensor
Device: Total Knee Arthroplasty with Verasense sensor
Total Knee Arthroplasty with Verasense sensor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
gait assessment
Time Frame: 2 years
kinematic gait assessment using KneeKG
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
EQ-5D patient reported outcome measure
Time Frame: 2 years
Health status measure
2 years
Ligament releases
Time Frame: Intra-operative
Number of ligament releases required during knee replacement
Intra-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TKA VERA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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