Prospective Study Measuring Clinical Outcomes of Knee Arthroplasty Using the VERASENSE™ Knee System

January 9, 2017 updated by: Orthosensor, Inc.

The primary objectives of this evaluation are: 1) To attempt to refine the current clinical understanding of "balance" 2) To determine if patients with quantifiably balanced knee joints exhibit improved clinical outcomes versus patient with residual imbalance, as measured by the VERASENSE™ Knee System

Secondary objectives:

  • Determine whether a difference in inter-compartment loads and soft tissue tension exists between the physicians intra-operative feel compared to the quantifiable data measured by the VERASENSE™ Knee System
  • Determine which ligament releases are performed by the surgeon to improve soft tissue balance while utilizing the information from the VERASENSE™ Knee System
  • Evaluate range of motion, pain, physical function, activity level, and patient satisfaction between baseline (pre-operative) and post-operative follow-up as well as radiographic success and survivorship of the knee implants

Study Overview

Status

Status

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

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.

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.
Observational

Enrollment (Actual)

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.
285

Contacts and Locations

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

Study Locations

  • United States
    • California
      • St. Helena, California, United States, 94574
        • St. Helena Hospital
    • Florida
      • Fort Lauderdale, Florida, United States, 33334
        • Holy Cross Orthopedic Institute
      • Naples, Florida, United States, 34102
        • Naples Community Hospital
      • Tampa, Florida, United States, 33637
        • Tampa General/FORE
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Emory Healthcare - St. Joseph's Research Institute
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Spectrum Health/Orthopaedic Associates of Michigan
      • Port Huron, Michigan, United States, 48060
        • Trinity Health/Bone and Joint Institute
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

  • Subject must be a candidate for a primary total knee replacement
  • Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis post-traumatic arthritis
  • Subject's joint must be anatomically and functionally suited to receive the selected implant
  • Subject is 50 years of age or older (≥ 50 yrs) at the time of consent
  • Subject is likely to be available for all study visits
  • Subject is able and willing to sign the informed consent and follow study procedures
  • Subject is not pregnant

Exclusion Criteria:

  • Prior total knee arthroplasty
  • Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
  • Subject is pregnant
  • Subject has an active infection or joint sepsis
  • Subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Multiple Sclerosis, and Charcot joints)
  • Ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
  • Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees

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

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
Time Frame
Joint Balance
Time Frame: At time of Total Knee Surgery
At time of Total Knee Surgery

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
Time Frame
Patient Reported Outcome Measures
Time Frame: Changes from Baseline at 3-years
Changes from Baseline at 3-years

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.
Orthosensor, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kenneth Gustke, MD, Florida Orthopaedic Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

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.
October 1, 2011

Primary Completion (Actual)

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.
December 1, 2016

Study Completion (Actual)

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.
December 1, 2016

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).
November 8, 2011

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.
November 9, 2011

First Posted (Estimate)

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.
November 10, 2011

Study Record Updates

Last Update Posted (Estimate)

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.
January 11, 2017

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.
January 9, 2017

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, 2017

More Information

Terms related to this study

Keywords

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.
  • 1-Anderson

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Publication
    Information comments: 6-Month Report: Guske et al. A New Method for Defining Balance: Promising Short-term outcomes of Sensor-Guided TKA. J Arthroplasty. 2014 May;29(5):955-60
  2. Publication
    Information comments: 1-year Report: Gustke et al. Primary TKA patients with Quantifiably Balanced Soft-Tissue Achieve Significant Clinical Gains Sooner than Unbalanced Patients. Adv Orthop. 2014:628695

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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