Recruiting

Intellirod

Sponsor:

Intellirod Spine

Code:

NCT02768675

Conditions

Kyphosis

Spinal Fractures

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

LOADPRO

Study Details

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.

Conditions

Kyphosis

Spinal Fractures

Study ID

NCT02768675

Start date

May, 2016

Status verified date

Aug, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

LOADPRO

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

Primary outcome measure

  • Bilateral Rod Strain Readings [ Time Frame: Intra-operative ]

Central Contacts and Locations

Central contacts

Richard N Navarro

234-678-8965rnavarro@intellirodspine.com

Mary L Lewis

440-801-1540mlewis@imarcresearch.com

Locations

Norton Leatherman Spine Center

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Jeffrey L Gum, MD

502-584-7525jlgum001@gmail.com

Principal Investigator:

Jeffrey L Gum, MD

OhioHealth Neurological Physicians

Recruiting

Columbus, Ohio, United States, 43215

Contacts

Chris S Karas, MD

614-566-9777Chris.Karas@ohiohealth.com

Principal Investigator:

Chris S Karas, MD

More Information

Sponsor

Intellirod Spine

Last update posted

Aug 22, 2017

Last verified

Aug, 2017

Keywords

  • Kyphotic
  • Corrective Surgery
  • Spinal fractures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Intellirod Spine on 2017-08-22.