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

I

Intellirod Spine

Status

Unknown

Conditions

Spinal Fractures
Kyphosis

Treatments

Device: LOADPRO

Study type

Interventional

Funder types

Industry

Identifiers

NCT02768675
LOADPRO EX-0029

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

LOADPRO arm
Experimental group
Description:
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.
Treatment:
Device: LOADPRO

Trial contacts and locations

2

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Central trial contact

Richard N Navarro; Mary L Lewis

Data sourced from clinicaltrials.gov

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