To Determine the Gait and Functional Improvement in Total Knee Arthroplasty
NCT ID: NCT04057885
Last Updated: 2020-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-05-15
2018-07-31
Brief Summary
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Detailed Description
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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) and patient perception of a balanced knee
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Device Arm
A prospective series of 10 patients will receive sensor-guided TKA using the this special Orthosensor™ VERASENSE™ Knee System assisted surgery for optimization of soft tissue balance
Orthosensor™ VERASENSE™ Knee System
A group of patients will receive a total knee arthroplasty using the Orthosensor device
Standard of Care
10 patients will receive standard of care. Prior to cementing final implants, VERASENSE will be utilized with the standard of care group with the surgeon blinded to the data.
Orthosensor™ VERASENSE™ Knee System
A group of patients will receive a total knee arthroplasty using the Orthosensor device
Interventions
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Orthosensor™ VERASENSE™ Knee System
A group of patients will receive a total knee arthroplasty using the Orthosensor device
Eligibility Criteria
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Inclusion Criteria
* Subject must be diagnosed with one or more of the following conditions:
1. osteoarthritis
2. avascular necrosis
3. rheumatoid or other inflammatory arthritis
4. post-traumatic arthritis Minimum age: 45 Maximum age: 80
* 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
2. ligament insufficiencies
3. prior surgeries such as:
1. ACL or PCL reconstructions
2. posterolateral reconstructions
3. osteotomies
4. tibia plateau fractures
5. Range of Motion less than 90 degrees f ) flexion contracture of more than 20 degrees
45 Years
80 Years
ALL
No
Sponsors
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Orthosensor, Inc.
INDUSTRY
LifeBridge Health
OTHER
Responsible Party
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Principal Investigators
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Michael A. Mont, M.D.
Role: PRINCIPAL_INVESTIGATOR
Director, Rubin Institute for Advanced Orthopedics and Joint Preservation
Locations
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Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Countries
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Other Identifiers
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Orthosensor 101
Identifier Type: -
Identifier Source: org_study_id
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