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Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During TKA

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TKA with "Verasense"
TKA without "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 Total Knee Arthroplasty, Rotational Alignment, Intraoperative Sensors, Patient Outcomes, Soft Tissue Balance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who meet the indications for use for Triathlon® Total Knee System using VERASENSE™
  • Subject must be diagnosed with one or more of the following conditions
  • osteoarthritis
  • rheumatoid or other inflammatory arthritis
  • post-traumatic arthritis
  • 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
  • Avascular Necrosis
  • Any knee surgery other than meniscectomy (can be arthroscopic or open)
  • Ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
  • Ipsilateral foot/ankle and hip arthritis
  • Range of motion less than 90°, flexion contracture greater than 20°
  • Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
  • Any subjects meeting any contraindication criteria as identified in the locally approved labeling for the device should be excluded from this study.

Sites / Locations

  • The Cleveland Clinic FoundationRecruiting
  • Emory UniversityRecruiting
  • Illinois Bone & Joint InstituteRecruiting
  • NYU Hospital for Joint DiseasesRecruiting
  • The Cleveland Clinic FoundationRecruiting
  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Group A TKA without VERASENSE

Group B TKA with VERASENSE

Arm Description

will consist of 250 consecutive patients who will undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance.

will consist of 250 consecutive patients who will undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance.

Outcomes

Primary Outcome Measures

Knee Society Pain and Functional Scoring

Secondary Outcome Measures

Anterior Knee Pain Evaluation
EQ5D
Forgotten Joint Score

Full Information

First Posted
October 31, 2014
Last Updated
April 4, 2017
Sponsor
Orthosensor, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02286739
Brief Title
Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During TKA
Official Title
Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray rotation to the mid-third of the tibial tubercle. 2) Understand if patients with a combined axial rotation couple at the tibiofemoral joint and quantitative intercompartmental balance, achieved with the use of VERASENSE, exhibit less post-operative knee pain and improved clinical outcomes. Radiographic outcomes will also be assessed to measure post-operative alignment and to evaluate the prevalence and location of radiolucency and/or osteolysis.
Detailed Description
Hypothesis: TKA with VERASENSE results in a more reliable and precise option for establishing implant-to-implant congruency and joint balance leading to less knee pain, faster return to normal activities and higher patient satisfaction compared to TKA without VERASENSE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Total Knee Arthroplasty, Rotational Alignment, Intraoperative Sensors, Patient Outcomes, Soft Tissue Balance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A TKA without VERASENSE
Arm Type
Sham Comparator
Arm Description
will consist of 250 consecutive patients who will undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance.
Arm Title
Group B TKA with VERASENSE
Arm Type
Active Comparator
Arm Description
will consist of 250 consecutive patients who will undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance.
Intervention Type
Device
Intervention Name(s)
TKA with "Verasense"
Intervention Description
VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA 510K clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.
Intervention Type
Procedure
Intervention Name(s)
TKA without "Verasense"
Intervention Description
TKA will be performed manually without the use of Verasense
Primary Outcome Measure Information:
Title
Knee Society Pain and Functional Scoring
Time Frame
Changes from baseline at 24 months
Secondary Outcome Measure Information:
Title
Anterior Knee Pain Evaluation
Time Frame
Changes from baseline at 24 months
Title
EQ5D
Time Frame
Changes from baseline at 24 months
Title
Forgotten Joint Score
Time Frame
Changes from baseline at 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who meet the indications for use for Triathlon® Total Knee System using VERASENSE™ Subject must be diagnosed with one or more of the following conditions osteoarthritis rheumatoid or other inflammatory arthritis post-traumatic arthritis 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 Avascular Necrosis Any knee surgery other than meniscectomy (can be arthroscopic or open) Ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures Ipsilateral foot/ankle and hip arthritis Range of motion less than 90°, flexion contracture greater than 20° Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease) Any subjects meeting any contraindication criteria as identified in the locally approved labeling for the device should be excluded from this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher R. Anderson, MS, MBA
Phone
(954) 372-2641
Email
canderson@orthosensor.com
First Name & Middle Initial & Last Name or Official Title & Degree
Leah C. Elson, BS
Phone
954-577-7770
Email
lelson@orthosensor.com
Facility Information:
Facility Name
The Cleveland Clinic Foundation
City
Weston
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilia Calvo
Email
calvoc@ccf.org
First Name & Middle Initial & Last Name & Degree
Preetesh Patel, MD
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jared O'Neal
Email
jwoneal@emory.edu
First Name & Middle Initial & Last Name & Degree
Thomas Bradbury, MD
Facility Name
Illinois Bone & Joint Institute
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy R Cipparrone
Email
ncipparrone@ibji.com
First Name & Middle Initial & Last Name & Degree
Alexander Gordon, MD
Facility Name
NYU Hospital for Joint Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariel Aponte, CCRC
Email
ariel.aponte@nyumc.org
First Name & Middle Initial & Last Name & Degree
Ivan Fernandez-Madrid, MD
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gannon Curtis, MD
Email
curtisg@ccf.org
First Name & Middle Initial & Last Name & Degree
Wael Barsoum, MD
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Hansen
Email
mhansen@mcvh-vcu.edu
First Name & Middle Initial & Last Name & Degree
Gregory Golladay, MD

12. IPD Sharing Statement

Learn more about this trial

Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During TKA

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