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Orthosensor vs Conventional Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03628378
Recruitment Status : Active, not recruiting
First Posted : August 14, 2018
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Geller, Columbia University

Brief Summary:
In a randomized-controlled fashion, this investigation will evaluate the use of the Verasense technology to achieve optimal TKA balance. Patients will be randomized to either: 1) undergo manual soft tissue balancing or 2) soft tissue balancing with the Verasense. The primary outcomes of interest will include patient-reported outcomes as well knee range of motion at 3 months, 6 months, 1 year, and 2 years. Secondary outcomes of interest will include pain level as assessed by the visual analogue scale (VAS) in the acute post-operative and follow up periods, ambulation distance during inpatient physical therapy postoperatively, surgical time, tourniquet time, amount of opioid consumption, length of hospital stay, incidence of arthrofibrosis and subsequent manipulation under anesthesia. The investigators hypothesize that the use of the Verasense technology will lead to improved soft tissue balancing in TKA and ultimately result in favorable patient-reported outcomes and postoperative knee range of motion.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Verasense Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Outcomes in Free-hand Versus Sensor-guided Balancing in Total Knee Arthroplasty: a Randomized Controlled Trial
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : March 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
No Intervention: Non-Sensor Group
Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.
Experimental: Sensor Group
Patients will undergo total knee replacement surgery with Verasense assisted balancing technology.
Device: Verasense
Ligamentous balancing device
Other Name: Orthosensor




Primary Outcome Measures :
  1. Veterans RAND12 Item Health Survey [ Time Frame: 1 year ]
    The investigators will ask participants to answer survey questions about knee functionality on a scale of 0-100, 0 being the least functionality and 100 being the most.


Secondary Outcome Measures :
  1. Visual Analogue Scale pain level [ Time Frame: 1 week ]
    Pain levels on a scale from 1-10 (1 being the least amount of pain possible and 10 being the most amount of pain possible).

  2. Ambulation (distance) [ Time Frame: 1 week ]
    ambulation distance during inpatient physical therapy postoperatively

  3. Range of motion [ Time Frame: 1 year ]
    physical examination of knee

  4. KOOS Knee Survey [ Time Frame: 1 year ]
    The investigators will ask participants to answer survey questions about knee functionality on a scale of 0-100, 0 being the least functionality and 100 being the most.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary total knee replacement

Exclusion Criteria:

  • Revision knee surgery
  • Prior knee surgery

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): NCT03628378


Locations
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United States, New York
NewYork-Presbyterian Lawrence Hospital
Bronxville, New York, United States, 10708
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Jeffrey Geller, MD Columbia University
Publications:

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Responsible Party: Jeffrey Geller, Professor of Orthopaedic Surgery, Columbia University
ClinicalTrials.gov Identifier: NCT03628378    
Other Study ID Numbers: AAAR6137
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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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
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases