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PILOT STUDY: Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing: A Randomized, Double-Blind, Controlled Trial

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ClinicalTrials.gov Identifier: NCT02290119
Recruitment Status : Unknown
Verified April 2017 by Orthosensor, Inc..
Recruitment status was:  Recruiting
First Posted : November 13, 2014
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Orthosensor, Inc.

Brief Summary:

The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and correlate Intra-operative subjective feel with OrthoSensor Outputs

Secondary objectives are to quantify and observe:

  • Pain medication use
  • Swelling
  • Muscle strength and girth
  • Gait efficiency
  • Patient satisfaction
  • Activity levels, functional return (i.e., back to work, resume normal activities)
  • Patient perception of a balanced knee

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Sensor-assisted TKR (Verasense) Procedure: Control - Without the use of Verasense Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Study Start Date : May 2014
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Sham Comparator: Control - Without the use of Verasense
Total Knee Replacement without the use of intraoperative sensors
Procedure: Control - Without the use of Verasense
Patients in this cohort will undergo manual total knee replacement without the use of Verasense

Active Comparator: Sensor-assisted TKR (Verasense)
Total Knee Replacement with the use of intraoperative sensors
Device: Sensor-assisted TKR (Verasense)
Verasense is a single use, disposable device embedded with microelectronics into a standard tibial trial to provide dynamic, intraoperative feedback regarding limb alignment, tibiofermoral position and quantitative pressure at peak contact points in the medial and lateral compartments during total knee replacement surgery. Utilizing sensor-derived data, the surgeon can now evaluate intercompartmental loading throughout the range of motion, and correct for soft-tissue abnormalities while receiving real-time feedback regarding joint balance.




Primary Outcome Measures :
  1. Rehabilitation Potential [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Knee Society Pain and Functional Scoring [ Time Frame: 6 month ]
  2. Forgotten Joint Assessment [ Time Frame: 6 month ]
  3. 3D Gait Analysis [ Time Frame: 6 Month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject must be a candidate for a primary PCL retaining total knee arthroplasty
  • Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis, post-traumatic arthritis
  • Subject is between the age of 45 - 80 years
  • 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, ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
  • Range of Motion less than 90 degrees, flexion contracture of more than 20 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): NCT02290119


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

Locations
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United States, Maryland
Sinai Hospital of Baltimore - Rubin Institute of Advanced Orthopedics Center for Joint Preservation and Reconstruction Recruiting
Baltimore, Maryland, United States
Contact: Anil Behave, PT       anilbhave@gmail.com   
Principal Investigator: Michael A Mont, MD         
Sponsors and Collaborators
Orthosensor, Inc.
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Responsible Party: Orthosensor, Inc.
ClinicalTrials.gov Identifier: NCT02290119    
Other Study ID Numbers: 101
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Keywords provided by Orthosensor, Inc.:
Primary PCL-retaining Total Knee Arthroplasty
Intraoperative Sensors
Ligament Balancing
Clinical Outcomes
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases