Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
NCT ID: NCT02768675
Last Updated: 2017-08-22
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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UNKNOWN
NA
12 participants
INTERVENTIONAL
2016-05-31
2018-12-31
Brief Summary
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Detailed Description
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This non-significant risk case series is intended to assess the effectiveness of the Intellirod LOADPRO™ sensor methodology and the intra-operative measurement of spinal rod strain. The LOADPRO™ sensors will be removed from the spinal rods after obtaining load measurements.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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LOADPRO arm
Participants will temporarily receive a LOADPRO device affixed to kyphotic corrective rods. The device will not be implanted and will be removed prior to surgery closure.
LOADPRO
The Intellirod LOADPRO sensor is a single-use, disposable instrument for the intra-operative measurement of posterior instrumented, spine rod strain.
Interventions
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LOADPRO
The Intellirod LOADPRO sensor is a single-use, disposable instrument for the intra-operative measurement of posterior instrumented, spine rod strain.
Eligibility Criteria
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Inclusion Criteria
* presenting with a confirmed diagnosis of kyphosis with deformity greater than 70 degrees requiring large segmental correction involving a minimum of six (6) levels
* failure of conservative therapy requiring surgical correction of sagittal imbalance
* sagittal imbalance due to loss of lumbar lordosis, and/or segmental kyphosis
* participated in the informed consent process and has signed an Institutional Review Board approved informed consent
Exclusion Criteria
* evidence of active (systemic or local) infection at time of surgery
* prisoner or transient
* history of known narcotic abuse
* psychological disturbance past or present that could impair the consent process or ability to complete subject self-report questionnaires
* ASA \> 3
* osteoporosis diagnosed on DEXA defined as a T-score ≥ -2.0
* Unable or unwilling to provide a full informed consent
18 Years
65 Years
ALL
No
Sponsors
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Intellirod Spine
INDUSTRY
Responsible Party
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Principal Investigators
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Richard N Navarro
Role: STUDY_DIRECTOR
Intellirod Spine
Locations
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Norton Leatherman Spine Center
Louisville, Kentucky, United States
OhioHealth Neurological Physicians
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LOADPRO EX-0029
Identifier Type: -
Identifier Source: org_study_id
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