The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 37
- 主要终点
- Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)
研究概览
简要总结
The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s).
Subjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject provides written informed consent per institution and/or geographical requirements.
- •Subject is intended to receive or be treated with an eligible Medtronic Cranial and Spinal Technology (CST) device(s) (see product appendices), used alone or in combination, for a cranial and/or spinal indication(s).
- •Subject is at least 18 years of age or minimum legal age as required by local regulations.
- •Subject agrees to complete all required assessments per the Schedule of Events.
排除标准
- •Subject is currently enrolled or plans to enroll in concurrent drug/device/biologic trial(s) that may confound this trial's results per investigator assessment (i.e. no required intervention that could affect interpretation of all-around device safety and or performance).
- •Subject who is, or is expected to be, inaccessible for all required follow-up visits.
- •Subject with exclusion criteria required by local law.
- •Subject is considered vulnerable at the time of obtaining consent.
研究组 & 干预措施
Receiving eligible Medtronic device(s) from all product groups
Powered Systems, Instruments, and Imaging device(s), Advanced Energy device(s), Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s)
干预措施: Follow-up schedule: pre-operative baseline up to 24-months post-procedure (Device)
结局指标
主要结局
Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)
时间窗: Discharge (from Index Surgery completion to 14 days post-operatively)
Defined by amount of: 1) blood loss (mL) during surgery and/or 2) total operation time and/or 3) length of stay in the hospital (measured from surgery completion to discharge), and/or 4) investigator opinion on whether the device(s) directly assisted in the completion of surgery
Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used)
时间窗: 12 months
Fusion success at 12-months is determined through evaluation of radiographic evidence (X-ray and/or CT scan) by the investigator by: (1) Confirming the presence of bone bridging, and (2) if using the Brantigan \& Steffee's Classification scale: a score D and/or E are determined.
Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used)
时间窗: Index Surgery
Surgical performance, as defined as the rate at which the device directly assisted in the completion of surgery in the investigator's opinion. If O-Arm used: whether O-Arm was utilized for validation of implant placement during the surgery.
Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used)
时间窗: 24 months
Robotics: Planned number of screws prior to index surgery compared to number of screws device assisted with placement during surgery. Navigation: Whether or not device was utilized for validation of screw placement during surgery.
Pain Resolution (for select Medtronic eligible market-released Other Spinal Hardware device(s) used)
时间窗: 12 months
Resolution of pain at 12-months when compared to baseline Pain reported by the subject using the Neck Disability Index (NDI) questionnaire
Stabilization (for any Medtronic eligible market-released device(s) used from the following product groups: Other Spinal Hardware)
时间窗: Up to 12 months
* Stabilization is the radiographic verification of no noticeable hardware and/or implant loosening, the presence of the hardware in the appropriate position without cage subsidence and/or implant loosening, and noticeable stable alignment of the spine post-surgery. * Since all products are market-released, assessment for stabilization will be completed by the investigator. * Stabilization will be assessed by the collection of radiographic evidence (X-Ray(s) and CT-scan(s)).
Deformity Correction (for specified Medtronic eligible market-released device(s) used from the following product groups: Spinal Tethers)
时间窗: 12 months
Defined by the change of Cobb angle at 12-month
次要结局
- Rate of Device-related Adverse Events any Medtronic eligible market-released Cranial & Spinal Technologies (CST) device(s) as aligned with ISO 14155 standards(24 months)
- Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Rods and Screws](Up to 12 months)
- Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws](12 months)