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

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: Completed
• Conditions: Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis

• Study Type: Observational
• Enrollment (Actual): 285

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Joint Balance	At time of Total Knee Surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Orthosensor, Inc.
• Investigators: Principal Investigator: Kenneth Gustke, MD, Florida Orthopaedic Institute

Publications and helpful links

Helpful Links

• Sponsor website

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 8, 2011
• First Submitted That Met QC Criteria: November 9, 2011
• First Posted (Estimate): November 10, 2011

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Ligament Balance, Total Knee Arthroplasty, Intra-operative Sensors
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Necrosis
• Other Study ID 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