To Determine the Gait and Functional Improvement in Total Knee Arthroplasty

A PILOT STUDY: To Determine the Gait and Functional Improvement in Total Knee Arthroplasty With Use of Orthosensor™ VERASENSE™ Knee System for Soft Tissue Balancing.

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04057885

Acronym

Orthosensor

Enrollment

Registered

2019-08-15

Start date

2017-05-15

Completion date

2018-07-31

Last updated

2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Arthritis

Brief summary

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

Detailed description

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

Interventions

DEVICEOrthosensor™ VERASENSE™ Knee System

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients with improvement in gait.	18 months
Proportion of patients not requiring long term rehabilitation.	18 months
Proportion of patients with improved function as measured by standardized knee scores.	18 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026