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

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Key information

Conditions

Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteoarthritis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Helena Hospital, St. Helena, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Joint Balance

Time frame: At time of Total Knee Surgery

Secondary outcomes

Patient Reported Outcome Measures

Time frame: Changes from Baseline at 3-years

Sponsors and collaborators

Lead sponsor

Orthosensor, Inc.

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Nov 10, 2011
Registry last updated: Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed