Clinical trial NCT01469299: Prospective Study Measuring Clinical Outcomes of Knee Arthroplasty Using the VERASENSE™ Knee System
Official title: Prospective Study Measuring Clinical Outcomes of Knee Arthroplasty Using the VERASENSE™ Knee System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis
Keywords: Ligament Balance, Total Knee Arthroplasty, Intra-operative Sensors
Lead sponsor: Orthosensor, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-10
Enrollment: 285
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

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


Eligibility 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

Primary outcomes:
measure: Joint Balance
timeFrame: At time of Total Knee Surgery
Secondary outcomes:
measure: Patient Reported Outcome Measures
timeFrame: Changes from Baseline at 3-years
Other outcomes:
Locations:
city: St. Helena
country: United States
facility: St. Helena Hospital
state: California
city: Fort Lauderdale
country: United States
facility: Holy Cross Orthopedic Institute
state: Florida
city: Naples
country: United States
facility: Naples Community Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General/FORE
state: Florida
city: Atlanta
country: United States
facility: Emory Healthcare - St. Joseph's Research Institute
state: Georgia
city: Grand Rapids
country: United States
facility: Spectrum Health/Orthopaedic Associates of Michigan
state: Michigan
city: Port Huron
country: United States
facility: Trinity Health/Bone and Joint Institute
state: Michigan
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Florida Orthopaedic Institute
name: Kenneth Gustke, MD
role: PRINCIPAL_INVESTIGATOR
References: