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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.
The Intellirod LOADPROâ„¢ 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 LOADPROâ„¢ sensor methodology and the intra-operative measurement of spinal rod strain. The LOADPROâ„¢ sensors will be removed from the spinal rods after obtaining load measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOADPRO | Device | The Intellirod LOADPRO sensor is a single-use, disposable instrument for the intra-operative measurement of posterior instrumented, spine rod strain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Back and bilateral leg pain | (0 to 10) rating scale | up to 1 year post-procedure |
| Patient Questionnaire | Scoliosis Research Society 22-r | up to 1 year post-procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard N Navarro | Contact | 234-678-8965 | rnavarro@intellirodspine.com | |
| Mary L Lewis | Contact | 440-801-1540 | 210 | mlewis@imarcresearch.com |
| Name | Affiliation | Role |
|---|---|---|
| Richard N Navarro | Intellirod Spine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norton Leatherman Spine Center | Recruiting | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D007738 | Kyphosis |
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| OhioHealth Neurological Physicians | Recruiting | Columbus | Ohio | 43215 | United States |
|
| D013124 |
| Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |