To Determine the Gait and Functional Improvement in Total Knee Arthroplasty

LifeBridge Health

Overview

This is an observational study to understand the effects of soft-tissue balancing on gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty

The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and to correlate Intra-operative subjective feel with OrthoSensor Outputs Secondary objectives are to quantify and observe pain medication use, swelling, muscle strength and girth, gait efficiency, patient satisfaction, activity levels, functional return (i.e., back to work, resume normal activities) and patient perception of a balanced knee

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Degenerative Arthritis

Interventions

Orthosensor™ VERASENSE™ Knee SystemDEVICE

A group of patients will receive a total knee arthroplasty using the Orthosensor device

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject must be a candidate for a primary PCL retaining total knee arthroplasty * Subject must be diagnosed with one or more of the following conditions: 1. osteoarthritis 2. avascular necrosis 3. rheumatoid or other inflammatory arthritis 4. post-traumatic arthritis Minimum age: 45 Maximum age: 80 * Subject is likely to be available for all study visits * Subject is able and willing to sign the informed consent and follow study procedures Exclusion Criteria 1. Prior total knee arthroplasty 2. ligament insufficiencies 3. prior surgeries such as: 1. ACL or PCL reconstructions 2. posterolateral reconstructions 3. osteotomies 4. tibia plateau fractures 5. Range of Motion less than 90 degrees f ) flexion contracture of more than 20 degrees

Locations (1)

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Proportion of patients with improvement in gait.

Time frame: 18 months

Proportion of patients not requiring long term rehabilitation.

Time frame: 18 months

Proportion of patients with improved function as measured by standardized knee scores.

Time frame: 18 months

Data from ClinicalTrials.gov

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