NCT01220505已完成不适用
A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- Maintenance of Deformity Correction
研究概览
简要总结
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System & Trivium 3D Spinal Deformity Correction System.
详细描述
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System & Trivium 3D Spinal Deformity Correction System. We have extended the study tol collect further outcomes data at the 12 month time point.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •200 subjects at 10 clinical centers.
- •All subjects undergoing spinal fusion surgery between the levels of T1- Ilium (Thoracic 1 to Ilium)
- •All subjects are skeletally mature with spinal deformity.
- •Risser score must be ≥
- •Subjects or their representative must be willing and able to give informed consent and assent (if applicable).
- •Subjects who do not meet any of the following contraindications: spinal infection or inflammation, morbid obesity, mental illness, alcoholism, drug abuse, pregnancy, metal sensitivity, foreign body sensitivity, patients with inadequate tissue coverage over the operative site, open wounds local to the operative area, any case not described in the specific indications
排除标准
- •Any subject who does not meet the inclusion criteria
结局指标
主要结局
Maintenance of Deformity Correction
时间窗: 6 months
The primary outcome measure for this trial will be the percentage of subjects who have maintained their degree of deformity correction within 10% from immediate post-op to the 6 month follow-up visit.
次要结局
- Decreased Operative Time(6 Months)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
EDWARDS INTUITY Valve System FOUNDATION StudyAortic Valve DiseaseRapid Deployment ValvesAortic StenosisNCT02338154Edwards Lifesciences516
已完成
不适用
MaxAn Post Market Surveillance ValidationDeformityFractureTumorDDDNCT01343693Zimmer Biomet119
已完成
不适用
MANTA Registry for Vascular Large-bore ClosureFemoral Arteriotomy ClosureNCT03330002Essential Medical, Inc.500
终止
不适用
Heart Lung Machine RegistryCardiac SurgeryThoracic SurgeryVascular SurgeryCardiopulmonary BypassNCT06159517Maquet Cardiopulmonary GmbH184
招募中
不适用
Ethicon Pelvic Mesh Post Market Clinical Follow-up RegistryPelvic Organ ProlapseStress Urinary IncontinenceNCT04829175Ethicon, Inc.1,000