Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyph… (NCT02768675) | Clinical Trial Compass
UnknownNot Applicable
Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
United States12 participantsStarted 2016-05
Plain-language summary
The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility assessment of the Intellirod LOADPROâ„¢ System measuring spinal rod strain in long spinal kyphotic corrective constructs.
Who can participate
Age range18 Years – 65 Years
SexALL
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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