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

Primary Purpose

Degenerative Arthritis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Orthosensor™ VERASENSE™ Knee System
Sponsored by
LifeBridge Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Arthritis

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sinai Hospital of Baltimore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Device Arm

Standard of Care

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 12, 2015
Last Updated
February 24, 2020
Sponsor
LifeBridge Health
Collaborators
Orthosensor, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04057885
Brief Title
To Determine the Gait and Functional Improvement in Total Knee Arthroplasty
Acronym
Orthosensor
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Lead Investigator no longer with institution
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeBridge Health
Collaborators
Orthosensor, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device Arm
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Orthosensor™ VERASENSE™ Knee System
Intervention Description
A group of patients will receive a total knee arthroplasty using the Orthosensor device
Primary Outcome Measure Information:
Title
Proportion of patients with improvement in gait.
Time Frame
18 months
Title
Proportion of patients not requiring long term rehabilitation.
Time Frame
18 months
Title
Proportion of patients with improved function as measured by standardized knee scores.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: osteoarthritis avascular necrosis rheumatoid or other inflammatory arthritis 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 Prior total knee arthroplasty ligament insufficiencies prior surgeries such as: ACL or PCL reconstructions posterolateral reconstructions osteotomies tibia plateau fractures Range of Motion less than 90 degrees f ) flexion contracture of more than 20 degrees
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A. Mont, M.D.
Organizational Affiliation
Director, Rubin Institute for Advanced Orthopedics and Joint Preservation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

To Determine the Gait and Functional Improvement in Total Knee Arthroplasty

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