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

NCT02768675 | Unknown

• 1 other identifier: LOADPRO EX-0029
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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

Keywords

Kyphotic; Corrective Surgery; Spinal fractures

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (2)

• Back and bilateral leg pain

  up to 1 year post-procedure

• Patient Questionnaire

  up to 1 year post-procedure

Study Arms (1)

LOADPRO arm

EXPERIMENTAL

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.

Device: LOADPRO

Interventions

LOADPRO DEVICE

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

LOADPRO arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intellirod Spine: lead

Study Sites (2)

Norton Leatherman Spine Center

Louisville, Kentucky, 40202, United States

RECRUITING

OhioHealth Neurological Physicians

Columbus, Ohio, 43215, United States

RECRUITING

MeSH Terms

Conditions

Kyphosis; Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Richard N Navarro

  Intellirod Spine

  STUDY DIRECTOR

Central Study Contacts

Richard N Navarro

CONTACT

234-678-8965; rnavarro@intellirodspine.com

Mary L Lewis

CONTACT

440-801-1540; mlewis@imarcresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 11, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)