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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: Intellirod Spine

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Intellirod Spine

Dates:
Date Received: May 5, 2016
Date Started: May 2016
Date Completion: December 2017
Last Updated: May 10, 2016
Last Verified: May 2016