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Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery (LOADPRO)

Primary Purpose

Kyphosis, Spinal Fractures

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LOADPRO
Sponsored by
Intellirod Spine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Kyphosis focused on measuring Kyphotic, Corrective Surgery, Spinal fractures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • between 18 and 65 years of age
  • 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:

  • women who are pregnant
  • 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

Sites / Locations

  • Norton Leatherman Spine CenterRecruiting
  • OhioHealth Neurological PhysiciansRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LOADPRO arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Bilateral Rod Strain Readings
In this research study, the LOADPRO device will be used solely to monitor and record rod strain readings. The device is not intended, and won't be used, to control or make any rod adjustments by the operative surgeon. In order to provide assurance that the readings cannot be used to make adjustments intra-operatively, the surgeon investigators will be blinded to the rod strain measurement readings.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2016
Last Updated
August 18, 2017
Sponsor
Intellirod Spine
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1. Study Identification

Unique Protocol Identification Number
NCT02768675
Brief Title
Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
Acronym
LOADPRO
Official Title
Intra-Operative Assessment of the Intellirod LOADPRO Disposable Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intellirod Spine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility assessment of the Intellirod LOADPRO™ System measuring spinal rod strain in long spinal kyphotic corrective constructs.
Detailed Description
The Intellirod LOADPRO™ sensor is an intra-operative titanium and ceramic, single use, disposable, strain sensing device, which includes hermetically sealed, micro electromechanical systems (MEMS) and radio-frequency identification (RFID) technology to enable measurement of intra-operative rod strain values. The transponder attaches to any commercially available 5.5mm diameter CoCr or Ti Alloy rod commonly used for posterior pedicle fixation systems. The transponder is used only to acquire rod strain values and a unique device identification code, which is obtained by a hand-held reader, providing real-time, objective measurement of the mechanical rod strain. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kyphosis, Spinal Fractures
Keywords
Kyphotic, Corrective Surgery, Spinal fractures

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LOADPRO arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
LOADPRO
Intervention Description
The Intellirod LOADPRO sensor is a single-use, disposable instrument for the intra-operative measurement of posterior instrumented, spine rod strain.
Primary Outcome Measure Information:
Title
Bilateral Rod Strain Readings
Description
In this research study, the LOADPRO device will be used solely to monitor and record rod strain readings. The device is not intended, and won't be used, to control or make any rod adjustments by the operative surgeon. In order to provide assurance that the readings cannot be used to make adjustments intra-operatively, the surgeon investigators will be blinded to the rod strain measurement readings.
Time Frame
Intra-operative
Other Pre-specified Outcome Measures:
Title
Back and bilateral leg pain
Description
(0 to 10) rating scale
Time Frame
up to 1 year post-procedure
Title
Patient Questionnaire
Description
Scoliosis Research Society 22-r
Time Frame
up to 1 year post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: between 18 and 65 years of age 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: women who are pregnant 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard N Navarro
Phone
234-678-8965
Email
rnavarro@intellirodspine.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mary L Lewis
Phone
440-801-1540
Ext
210
Email
mlewis@imarcresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard N Navarro
Organizational Affiliation
Intellirod Spine
Official's Role
Study Director
Facility Information:
Facility Name
Norton Leatherman Spine Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Gum, MD
Phone
502-584-7525
Email
jlgum001@gmail.com
First Name & Middle Initial & Last Name & Degree
Jeffrey L Gum, MD
Facility Name
OhioHealth Neurological Physicians
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris S Karas, MD
Phone
614-566-9777
Email
Chris.Karas@ohiohealth.com
First Name & Middle Initial & Last Name & Degree
Chris S Karas, MD
First Name & Middle Initial & Last Name & Degree
Kailash Narayan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery

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