To Determine the Gait and Functional Improvement in Total Knee Arthroplasty (Orthosensor)

February 24, 2020 updated by: LifeBridge Health

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.

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Device Arm
A prospective series of 10 patients will receive sensor-guided TKA using the this special Orthosensor™ VERASENSE™ Knee System assisted surgery for optimization of soft tissue balance
Device: Orthosensor™ VERASENSE™ Knee System
A group of patients will receive a total knee arthroplasty using the Orthosensor device
ACTIVE_COMPARATOR: Standard of Care
10 patients will receive standard of care. Prior to cementing final implants, VERASENSE will be utilized with the standard of care group with the surgeon blinded to the data.
Device: Orthosensor™ VERASENSE™ Knee System
A group of patients will receive a total knee arthroplasty using the Orthosensor device

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeBridge Health

Collaborators

Orthosensor, Inc.

Investigators

  • Principal Investigator: Michael A. Mont, M.D., Director, Rubin Institute for Advanced Orthopedics and Joint Preservation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2017

Primary Completion (ACTUAL)

July 31, 2018

Study Completion (ACTUAL)

July 31, 2018

Study Registration Dates

First Submitted

June 12, 2015

First Submitted That Met QC Criteria

August 14, 2019

First Posted (ACTUAL)

August 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Orthosensor 101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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