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

NCT01469299 | Completed

• 1 other identifier: 1-Anderson
• Study Type: observational
• Target: 285
• Locations: 1 country
• Sites: 8

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

Keywords

Ligament Balance, Total Knee Arthroplasty, Intra-operative Sensors

Outcome Measures

Primary Outcomes (1)

• Joint Balance

  At time of Total Knee Surgery

Secondary Outcomes (1)

• Patient Reported Outcome Measures

  Changes from Baseline at 3-years

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinic

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

Sponsors & Collaborators

• Orthosensor, Inc.: lead

Study Sites (8)

St. Helena Hospital

St. Helena, California, 94574, United States

Location

Holy Cross Orthopedic Institute

Fort Lauderdale, Florida, 33334, United States

Location

Naples Community Hospital

Naples, Florida, 34102, United States

Location

Tampa General/FORE

Tampa, Florida, 33637, United States

Location

Emory Healthcare - St. Joseph's Research Institute

Atlanta, Georgia, 30342, United States

Location

Spectrum Health/Orthopaedic Associates of Michigan

Grand Rapids, Michigan, 49525, United States

Location

Trinity Health/Bone and Joint Institute

Port Huron, Michigan, 48060, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kenneth Gustke, MD

  Florida Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 10, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

US (8)