Evaluation of Patients Treated With Patient Specific Rods: UNiD Rods Register
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 743
- 试验地点
- 13
- 主要终点
- Radiological performance compared to planning
研究概览
简要总结
Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD).
This study aims to assess performance, clinical outcomes and safety
详细描述
Despite decades of treatment and great diversity of instrumentation, the objective of sagittal spinal realignment in adult spinal deformity is achieved in only 38% of patients which reflects an inadequacy of the approach currently used.
Patient specific rods were created by Medicrea to address this gap and support surgeons in achieving what they planned to perform in terms of spinal correction based on preoperative X-rays analyses.
Beside to help surgeons in planning and to improve performance, the avoidance of manual bending is supposed to save time during surgery and to limit notches which should then reduce rod fractures responsible for surgical revisions.
A European register-like study has been set-up to assess radiological performance, clinical outcomes and revision rate following implantation of patient-specific rods in adult spinal deformities
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient operated with UNiD® Patient Specific rods from MEDICREA® INTERNATIONAL
- •Patient affiliated to health care insurance (social security in France)
- •Patient able to complete a self-administered questionnaire
- •Patient able to sign a disclosure form or a non-opposition form
排除标准
- •Patient not operated with Patient Specific rods from MEDICREA® INTERNATIONAL
- •Pregnant patient
- •Patient not affiliated to health care insurance (social security in France)
- •Patient unable to sign a disclosure form
- •Patient unable to complete a self-administered questionnaire
结局指标
主要结局
Radiological performance compared to planning
时间窗: 12 months
The primary objective is to compare the planned sagittal parameters with those obtained postoperatively including but not limited to: * Sagittal vertical axis (SVA) * Lumbar Lordosis (LL) * Thoracic Kyphosis (TK) * Pelvic Tilt (PT) * Pelvic Incidence (PI) * Sacral Slope (SS) * Cobb Angle (CA)
次要结局
- Revision(3, 6, 12, 24 months)
- Postoperative spinal alignment(3, 6, 12, 24 months)
- Quality of life/ SRS-22(3, 6, 12, 24 months)
- Diasbility(3, 6, 12, 24 months)
- Patients' satisfaction(3, 6, 12, 24 months)
- Adverse event(3, 6, 12, 24 months)
- Pain/VAS(3, 6, 12, 24 months)