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

Status unconfirmed · Not applicable

Conditions studied: Kyphosis, Spinal Fractures

In brief

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.

Key facts

Study ID

NCT02768675

Run by

Intellirod Spine

People needed

12

Starts

2016-05-01

Expected to finish

2018-12-01

Last updated by the study team

2017-08-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Norton Leatherman Spine Center — Louisville, Kentucky, United States (enrolling)
• OhioHealth Neurological Physicians — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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