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

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ClinicalTrials.gov Identifier: NCT02286739
Recruitment Status : Unknown
Verified April 2017 by Orthosensor, Inc..
Recruitment status was:  Recruiting
First Posted : November 10, 2014
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Orthosensor, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: TKA with "Verasense" Procedure: TKA without "Verasense" Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty
Study Start Date : April 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Knee Society Pain and Functional Scoring [ Time Frame: Changes from baseline at 24 months ]

Secondary Outcome Measures :
  1. Anterior Knee Pain Evaluation [ Time Frame: Changes from baseline at 24 months ]
  2. EQ5D [ Time Frame: Changes from baseline at 24 months ]
  3. Forgotten Joint Score [ Time Frame: Changes from baseline at 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286739


Contacts
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Contact: Christopher R. Anderson, MS, MBA (954) 372-2641 canderson@orthosensor.com
Contact: Leah C. Elson, BS 954-577-7770 lelson@orthosensor.com

Locations
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United States, Florida
The Cleveland Clinic Foundation Recruiting
Weston, Florida, United States
Contact: Cecilia Calvo       calvoc@ccf.org   
Principal Investigator: Preetesh Patel, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Contact: Jared O'Neal       jwoneal@emory.edu   
Principal Investigator: Thomas Bradbury, MD         
United States, Illinois
Illinois Bone & Joint Institute Recruiting
Morton Grove, Illinois, United States, 60053
Contact: Nancy R Cipparrone       ncipparrone@ibji.com   
Principal Investigator: Alexander Gordon, MD         
United States, New York
NYU Hospital for Joint Diseases Recruiting
New York, New York, United States, 10003
Contact: Ariel Aponte, CCRC       ariel.aponte@nyumc.org   
Principal Investigator: Ivan Fernandez-Madrid, MD         
United States, Ohio
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Gannon Curtis, MD       curtisg@ccf.org   
Principal Investigator: Wael Barsoum, MD         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States
Contact: Megan Hansen       mhansen@mcvh-vcu.edu   
Principal Investigator: Gregory Golladay, MD         
Sponsors and Collaborators
Orthosensor, Inc.
More Information
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Responsible Party: Orthosensor, Inc.
ClinicalTrials.gov Identifier: NCT02286739    
Other Study ID Numbers: 102
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Keywords provided by Orthosensor, Inc.:
Total Knee Arthroplasty
Rotational Alignment
Intraoperative Sensors
Patient Outcomes
Soft Tissue Balance
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases