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

Completed

Conditions studied: Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis

In brief

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

Key facts

Study ID: NCT01469299
Run by: Orthosensor, Inc.
People needed: 285
Starts: 2011-10-01
Expected to finish: 2016-12-01
Last updated by the study team: 2017-01-11

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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