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Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensor-assisted TKR (Verasense)
Control - Without the use of Verasense
Sponsored by
Orthosensor, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoarthritis focused on measuring Primary PCL-retaining Total Knee Arthroplasty, Intraoperative Sensors, Ligament Balancing, Clinical Outcomes

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis, post-traumatic arthritis
  • Subject is between the age of 45 - 80 years
  • 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, flexion contracture of more than 20 degrees

Sites / Locations

  • Sinai Hospital of Baltimore - Rubin Institute of Advanced Orthopedics Center for Joint Preservation and Reconstruction

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Control - Without the use of Verasense

Sensor-assisted TKR (Verasense)

Arm Description

Total Knee Replacement without the use of intraoperative sensors

Total Knee Replacement with the use of intraoperative sensors

Outcomes

Primary Outcome Measures

Rehabilitation Potential

Secondary Outcome Measures

Knee Society Pain and Functional Scoring (KSS)
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Forgotten Joint Score (FJS)
The FJS is based on the patients' ability to forget about a joint as a result of the treatment. The FJS assessment is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.
3D Gait Analysis velocity
3D gait analysis relates to the range of motion of a joint and the movement velocity. The mean gait speed analysis is considered higher than 1 m/s.

Full Information

First Posted
October 31, 2014
Last Updated
February 2, 2023
Sponsor
Orthosensor, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02290119
Brief Title
Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing
Official Title
PILOT STUDY: Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing: A Randomized, Double-Blind, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
as a result of Orthosensor's acquisition by Stryker in July 2018.No final mutually agreed (signed) protocol was found and no clear records of the study data can be retrieved. No accurate and reliable results of this study can be posted.
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
October 12, 2022 (Actual)
Study Completion Date
October 12, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 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) 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
Osteoarthritis
Keywords
Primary PCL-retaining Total Knee Arthroplasty, Intraoperative Sensors, Ligament Balancing, Clinical Outcomes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control - Without the use of Verasense
Arm Type
Sham Comparator
Arm Description
Total Knee Replacement without the use of intraoperative sensors
Arm Title
Sensor-assisted TKR (Verasense)
Arm Type
Active Comparator
Arm Description
Total Knee Replacement with the use of intraoperative sensors
Intervention Type
Device
Intervention Name(s)
Sensor-assisted TKR (Verasense)
Intervention Description
Verasense is a single use, disposable device embedded with microelectronics into a standard tibial trial to provide dynamic, intraoperative feedback regarding limb alignment, tibiofemoral position and quantitative pressure at peak contact points in the medial and lateral compartments during total knee replacement surgery. Utilizing sensor-derived data, the surgeon can now evaluate intercompartmental loading throughout the range of motion, and correct for soft-tissue abnormalities while receiving real-time feedback regarding joint balance.
Intervention Type
Procedure
Intervention Name(s)
Control - Without the use of Verasense
Intervention Description
Patients in this cohort will undergo manual total knee replacement without the use of Verasense
Primary Outcome Measure Information:
Title
Rehabilitation Potential
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Knee Society Pain and Functional Scoring (KSS)
Description
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Time Frame
6 month
Title
Forgotten Joint Score (FJS)
Description
The FJS is based on the patients' ability to forget about a joint as a result of the treatment. The FJS assessment is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.
Time Frame
6 month
Title
3D Gait Analysis velocity
Description
3D gait analysis relates to the range of motion of a joint and the movement velocity. The mean gait speed analysis is considered higher than 1 m/s.
Time Frame
6 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Subject is between the age of 45 - 80 years 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, flexion contracture of more than 20 degrees
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Delanois, MD
Organizational Affiliation
Sinai Hospital of Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sinai Hospital of Baltimore - Rubin Institute of Advanced Orthopedics Center for Joint Preservation and Reconstruction
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215-5271
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing

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