Kyphosis, Spinal Fractures
Conditions
Keywords
Kyphotic, Corrective Surgery, Spinal fractures
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.
Detailed 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.
Interventions
DEVICELOADPRO
The Intellirod LOADPRO sensor is a single-use, disposable instrument for the intra-operative measurement of posterior instrumented, spine rod strain.
Sponsors
Intellirod Spine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bilateral Rod Strain Readings | Intra-operative | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Back and bilateral leg pain | up to 1 year post-procedure | (0 to 10) rating scale |
| Patient Questionnaire | up to 1 year post-procedure | Scoliosis Research Society 22-r |
Countries
United States
Contacts
Primary ContactRichard N Navarro
Backup ContactMary L Lewis
Outcome results
None listed