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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

Tracking Information
First Submitted Date  ICMJE May 5, 2016
First Posted Date  ICMJE May 11, 2016
Last Update Posted Date August 22, 2017
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 9, 2016)
  • Back and bilateral leg pain [ Time Frame: up to 1 year post-procedure ]
    (0 to 10) rating scale
  • Patient Questionnaire [ Time Frame: up to 1 year post-procedure ]
    Scoliosis Research Society 22-r
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
Official Title  ICMJE Intra-Operative Assessment of the Intellirod LOADPRO Disposable Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Kyphosis
  • Spinal Fractures
Intervention  ICMJE Device: LOADPRO
The Intellirod LOADPRO sensor is a single-use, disposable instrument for the intra-operative measurement of posterior instrumented, spine rod strain.
Study Arms  ICMJE 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.
Intervention: Device: LOADPRO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 9, 2016)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02768675
Other Study ID Numbers  ICMJE LOADPRO EX-0029
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Intellirod Spine
Study Sponsor  ICMJE Intellirod Spine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Richard N Navarro Intellirod Spine
PRS Account Intellirod Spine
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP