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.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Kyphosis Spinal Fractures||Device: LOADPRO||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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
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
|Contact: Richard N Navarroemail@example.com|
|Contact: Mary L Lewis||440-801-1540 ext firstname.lastname@example.org|
|United States, Kentucky|
|Norton Leatherman Spine Center||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Jeffrey L Gum, MD 502-584-7525 email@example.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|
|Study Director:||Richard N Navarro||Intellirod Spine|