Intra-Operative Assessment of the Intellirod LOADPRO Disposable Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Bilateral Rod Strain Readings
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •osteoporosis diagnosed on DEXA defined as a T-score ≥ -2.0
- •Unable or unwilling to provide a full informed consent
结局指标
主要结局
Bilateral Rod Strain Readings
时间窗: 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.
次要结局
未报告次要终点