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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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.
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT02768675

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Contact: Richard N Navarro 234-678-8965
Contact: Mary L Lewis 440-801-1540 ext 210

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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   
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   
Principal Investigator: Chris S Karas, MD         
Sub-Investigator: Kailash Narayan, MD         
Sponsors and Collaborators
Intellirod Spine
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Study Director: Richard N Navarro Intellirod Spine
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Responsible Party: Intellirod Spine 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:
Corrective Surgery
Spinal fractures
Additional relevant MeSH terms:
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Spinal Fractures
Fractures, Bone
Wounds and Injuries
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spinal Injuries
Back Injuries