Clinical trial NCT02768675: Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
Official title: Intra-Operative Assessment of the Intellirod LOADPRO Disposable Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kyphosis
Spinal Fractures
Keywords: Kyphotic
Corrective Surgery
Spinal fractures
Lead sponsor: Intellirod Spine
Sponsor class: INDUSTRY
First posted: 2016-05-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bilateral Rod Strain Readings
timeFrame: Intra-operative
Secondary outcomes:
Other outcomes:
measure: Back and bilateral leg pain
timeFrame: up to 1 year post-procedure
measure: Patient Questionnaire
timeFrame: up to 1 year post-procedure
Locations:
city: Louisville
country: United States
facility: Norton Leatherman Spine Center
state: Kentucky
city: Columbus
country: United States
facility: OhioHealth Neurological Physicians
state: Ohio
Study officials:
affiliation: Intellirod Spine
name: Richard N Navarro
role: STUDY_DIRECTOR
References: