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

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ClinicalTrials.gov Identifier: NCT02768675
Recruitment Status : Unknown
Verified August 2017 by Intellirod Spine.
Recruitment status was:  Recruiting
First Posted : May 11, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Intellirod Spine

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.

Condition or disease Intervention/treatment Phase
Kyphosis Spinal Fractures Device: LOADPRO Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Intra-Operative Assessment of the Intellirod LOADPRO Disposable Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
Study Start Date : May 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: LOADPRO
The Intellirod LOADPRO sensor is a single-use, disposable instrument for the intra-operative measurement of posterior instrumented, spine rod strain.




Primary Outcome Measures :
  1. Bilateral Rod Strain Readings [ Time Frame: Intra-operative ]
    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.


Other Outcome Measures:
  1. Back and bilateral leg pain [ Time Frame: up to 1 year post-procedure ]
    (0 to 10) rating scale

  2. Patient Questionnaire [ Time Frame: up to 1 year post-procedure ]
    Scoliosis Research Society 22-r



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02768675


Contacts
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Contact: Richard N Navarro 234-678-8965 rnavarro@intellirodspine.com
Contact: Mary L Lewis 440-801-1540 ext 210 mlewis@imarcresearch.com

Locations
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United States, Kentucky
Norton Leatherman Spine Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jeffrey L Gum, MD    502-584-7525    jlgum001@gmail.com   
Principal Investigator: Jeffrey L Gum, MD         
United States, Ohio
OhioHealth Neurological Physicians Recruiting
Columbus, Ohio, United States, 43215
Contact: Chris S Karas, MD    614-566-9777    Chris.Karas@ohiohealth.com   
Principal Investigator: Chris S Karas, MD         
Sub-Investigator: Kailash Narayan, MD         
Sponsors and Collaborators
Intellirod Spine
Investigators
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Study Director: Richard N Navarro Intellirod Spine
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Responsible Party: Intellirod Spine
ClinicalTrials.gov Identifier: NCT02768675    
Other Study ID Numbers: LOADPRO EX-0029
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Intellirod Spine:
Kyphotic
Corrective Surgery
Spinal fractures
Additional relevant MeSH terms:
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Kyphosis
Spinal Fractures
Fractures, Bone
Wounds and Injuries
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spinal Injuries
Back Injuries