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

NCT ID: NCT01469299

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 285 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2016-12-31

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthosensor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Gustke, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Orthopaedic Institute

Locations

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

Countries

United States

Study Documents

Document Type: Publication

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

View Document

Document Type: Publication

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

View Document

Other Identifiers

1-Anderson

Identifier Type: -

Identifier Source: org_study_id