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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01469299
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : January 11, 2017
Information provided by (Responsible Party):
Orthosensor, Inc.

Brief Summary:

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

Condition or disease
Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis

Study Type : Observational
Actual Enrollment : 285 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study Measuring Clinical Outcomes of Knee Arthroplasty Using the VERASENSE™ Knee System
Study Start Date : October 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Primary Outcome Measures :
  1. Joint Balance [ Time Frame: At time of Total Knee Surgery ]

Secondary Outcome Measures :
  1. Patient Reported Outcome Measures [ Time Frame: Changes from Baseline at 3-years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01469299

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

Additional Information:
Study Data/Documents: Publication  This link exits the site
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
Publication  This link exits the site
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

Responsible Party: Orthosensor, Inc. Identifier: NCT01469299     History of Changes
Other Study ID Numbers: 1-Anderson
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017

Keywords provided by Orthosensor, Inc.:
Ligament Balance, Total Knee Arthroplasty, Intra-operative Sensors

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes