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

April 4, 2017 updated by: Orthosensor, Inc.

Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

500

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 Contact

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States
        • Recruiting
        • The Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Preetesh Patel, MD
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Emory University
        • Contact:
        • Principal Investigator:
          • Thomas Bradbury, MD
    • Illinois
      • Morton Grove, Illinois, United States, 60053
        • Recruiting
        • Illinois Bone & Joint Institute
        • Contact:
        • Principal Investigator:
          • Alexander Gordon, MD
    • New York
      • New York, New York, United States, 10003
        • Recruiting
        • NYU Hospital for Joint Diseases
        • Contact:
        • Principal Investigator:
          • Ivan Fernandez-Madrid, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • The Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Wael Barsoum, MD
    • Virginia
      • Richmond, Virginia, United States
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Gregory Golladay, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Group A TKA without VERASENSE
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.
Procedure: TKA without "Verasense"
TKA will be performed manually without the use of Verasense
Active Comparator: Group B TKA with VERASENSE
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.
Device: TKA with "Verasense"
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee Society Pain and Functional Scoring
Time Frame: Changes from baseline at 24 months
Changes from baseline at 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Anterior Knee Pain Evaluation
Time Frame: Changes from baseline at 24 months
Changes from baseline at 24 months
EQ5D
Time Frame: Changes from baseline at 24 months
Changes from baseline at 24 months
Forgotten Joint Score
Time Frame: Changes from baseline at 24 months
Changes from baseline at 24 months

Collaborators and Investigators

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

Sponsor

Orthosensor, Inc.

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

April 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Osteoarthritis

Clinical Trials on TKA without "Verasense"

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe