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TKR With and Without the Use of Intra-operative Sensing

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251442
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Orthosensor, Inc.
Information provided by (Responsible Party):
Alejandro Gonzalez Della Valle, MD, Hospital for Special Surgery, New York

Brief Summary:

The purpose of this study is to determine if there is a difference in clinical outcomes after total knee replacement (TKR) performed with traditional ligament balancing compared to use of intraoperative sensing technology (IOS) to balance ligaments. IOS is used to send real time information to a monitor within the operating room that assists your surgeon in making decisions about the balance of the ligaments in your knee and the proper insertion of implants. A total of 150 subjects will participate in this study at Hospital for Special Surgery.

The hypotheses are that the use of IOS technology will be associated with:

  1. Better soft tissue balance during TKR than by manual balancing alone.
  2. Higher patient reported clinical outcome measures (PROMs) following surgery.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: OrthoSensor Verasense Technology Not Applicable

Detailed Description:

Participation in this study will involve a knee replacement performed with IOS. Patients will be randomized into one of two groups:The study group will have soft tissue balance performed with the use of IOS. Control group patients will have soft tissue balance performed manually, with final soft tissue balance values measured using IOS, while the surgeon will remain blinded to those values. Intra-operative compartment loads will be measured in 10, 45, and 90 degrees of flexion.

Additionally, long leg limb alignment, passive range of motion, use of opioids, daily activity, and PROMS will be evaluated post-operatively to determine which group has better outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Patients Undergoing a Total Knee Arthroplasty With and Without the Use of Intraoperative Sensing Technology
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Study Group
The study group will have soft tissue balance performed with the use of IOS.
Device: OrthoSensor Verasense Technology
IOS is used to send real time information to a monitor within the operating room that assists your surgeon in making decisions about the balance of the ligaments in your knee and the proper insertion of implants.

No Intervention: Control Group
Control group patients will have soft tissue balance performed manually, with final soft tissue balance values measured using IOS, while the surgeon will remain blinded to those values.



Primary Outcome Measures :
  1. Knee Society Score [ Time Frame: 4 months ]
    The primary outcome will be the difference in Knee Society Score (KSS) between baseline and 4 months post-operatively. The Knee Society Score is out of 100 points, with a higher score meaning a patient had a better outcome.


Secondary Outcome Measures :
  1. Intra-operative Compartment Loads [ Time Frame: Intra-operative ]
    Intra-operative compartment loads (medial and lateral component loads) will be measured between the groups at 10, 45, and 90 degrees of flexion during trial reduction and after cementation, using IOS technology.

  2. Long Leg Limb Alignment [ Time Frame: 6 weeks ]
    Long leg limb alignment will be measured on post-operative standard of care (SOC) radiographs at patients' 6 week follow-ups.

  3. Passive Range of Motion [ Time Frame: 4 months ]
    Passive range of motion will be measured pre-operatively, 6 weeks post-operatively, and 4 months post-operatively at all scheduled SOC appointments.

  4. Opioid Use [ Time Frame: 6 weeks ]
    Use of opioids will be tracked using the Internet System for Tracking Over Prescribing (I-STOP) database and a daily pain diary maintained by patient for first 6 weeks post-operatively. The I-STOP database can be accessed by the prescribing physician to track how many opioid refills a patient has procured.

  5. Function and Activity [ Time Frame: 6 weeks ]
    Function and activity will be monitored using Fitness Trackers. The device will be given to each patient in hospital and is to be worn for 6 weeks post-operatively. It will monitor a patient's daily and weekly steps while the patient is wearing it.

  6. Pain Level [ Time Frame: 6 weeks ]
    Daily pain levels will also be measured using the fitness tracker. The tracker will ask the patient to rate their pain on a scale from 0-10, with 0 meaning they have no pain, and 10 being the worst pain imaginable.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who meet the indications for use for primary TKR using IOS
  • Subject must be diagnosed with osteoarthritis
  • 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:

  • Revision total knee arthroplasty
  • Patient is receiving treatment for any of the following conditions:

    1. Avascular Necrosis
    2. Inflammatory arthritis
    3. Post-traumatic arthritis
  • Any knee surgery other than meniscectomy (can be arthroscopic or open)
  • Ligament insufficiencies, prior surgeries such as anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
  • Ipsilateral foot/ankle and hip arthritis
  • Range of motion less than 90°
  • 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.
  • Patient out-of-state with medication prescription not registered in iStop database
  • Patients with severe contralateral osteoarthritis requiring subsequent knee replacement or with a flexion contracture greater than 10 degrees.

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): NCT04251442


Contacts
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Contact: Kate Shanaghan 2127742490 shanaghank@hss.edu

Locations
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United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Kate Shanaghan    212-774-2490    shanaghank@hss.edu   
Sponsors and Collaborators
Hospital for Special Surgery, New York
Orthosensor, Inc.
Investigators
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Principal Investigator: Alejandro Gonzalez Della Valle, MD Hospital for Special Surgery, New York
Study Director: Kate Shanaghan Hospital for Special Surgery, New York
Publications of Results:
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Responsible Party: Alejandro Gonzalez Della Valle, MD, Professor of Clinical Orthopaedic Surgery, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT04251442    
Other Study ID Numbers: 2019-0144
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Keywords provided by Alejandro Gonzalez Della Valle, MD, Hospital for Special Surgery, New York:
Osteoarthritis
Total knee repalcement
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases