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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Orthosensor, Inc.
ClinicalTrials.gov Identifier:
NCT01469299
First received: November 8, 2011
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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
Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study Measuring Clinical Outcomes of Knee Arthroplasty Using the VERASENSE™ Knee System

Resource links provided by NLM:


Further study details as provided by Orthosensor, Inc.:

Primary Outcome Measures:
  • Joint Balance [ Time Frame: At time of Total Knee Surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: October 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469299

Locations
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.
  More Information

Additional Information:
No publications provided

Responsible Party: Orthosensor, Inc.
ClinicalTrials.gov Identifier: NCT01469299     History of Changes
Other Study ID Numbers: 1-Anderson
Study First Received: November 8, 2011
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014