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

Kyphosis Clinical Trial

— LOADPRO  

Official title:

Intra-Operative Assessment of the Intellirod LOADPRO Disposable Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02768675
• Other study ID #: LOADPRO EX-0029
• Status: Recruiting
• Phase: N/A
• First received: May 5, 2016
• Last updated: August 18, 2017
• Start date: May 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2017
• Source: Intellirod Spine
• Contact: Richard N Navarro
• Phone: 234-678-8965
• Email: rnavarro[@]intellirodspine.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Kyphosis
• Spinal Fractures

Intervention

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

Locations

Country	Name	City	State
United States	OhioHealth Neurological Physicians	Columbus	Ohio
United States	Norton Leatherman Spine Center	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Intellirod Spine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Back and bilateral leg pain	(0 to 10) rating scale	up to 1 year post-procedure
Other	Patient Questionnaire	Scoliosis Research Society 22-r	up to 1 year post-procedure
Primary	Bilateral Rod Strain Readings	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.	Intra-operative