InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 10
- 主要终点
- Instrumentations Used for Stabilization
研究概览
简要总结
It is a phase IV, national, multicenter, observational, retrospective study collecting data from patient medical files in French spinal centers.
The aim of the study is to describe the real world use of InductOs in Spine fusion in France.
Approximately 10 French centers will enroll 400 patients. The retrospective review of records will focus on patients who have undergone a spinal fusion surgery. Patient should be considered for enrollment if he/she has been treated with InductOs between January 1, 2011 and 31st December 2012.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
- •Patient as medical records documenting Study Procedure with at least: Age, sex, medical history, primary diagnostic indication, level(s) treated, procedure(s) type, interbody device's information if used
- •Patient has received the "information and non-objection letter" and reception is confirmed by registered courier
- •Patient is ≥18 years old at the date of the Study Procedure
排除标准
- •Patient declines participation
- •Vulnerable patients, unable to understand the non-objection letter or unable to exercise free decision to refuse to participate to the study (at investigator's discretion)
- •Patient died since study procedure*
- •Participation in concurrent interventional trial during study participation (from Study Procedure to last study follow-up) which may confound study results
结局指标
主要结局
Instrumentations Used for Stabilization
时间窗: during surgery
The number of spine levels using instrumentations for stabilization is presented by types of instrumentations.
The Primary Diagnostic Indication for InductOs Use
时间窗: Baseline
The primary diagnostic indications, which patients were treated with InductOs during spine fusion surgery in France, are presented.
Spine Levels Treated
时间窗: During surgery
The number of spine levels from the occiput to S1 is presented.
Primary Surgical Approaches Used for Implantation of InductOs
时间窗: During surgery
The surgical approaches for implanting InductOs are classified as anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), translateral lumbar interbody fusion (TLIF), lateral lumber interbody fusion (LLIF, including DLIF and XLIF), posterolateral fusion (PLF). The number of spine levels by surgical approaches is presented.
The Interbody Device Brand/Generic Names Used With InductOs
时间窗: during surgery
The number of spine levels with InductOs is presented by interbody brand/generic names.
Placement of the Matrix Wetted With InductOs
时间窗: During surgery
The placement of the matrix was classified as posterior lateral or interbody space (Inside the cage, between the cages or outside the cage) or any other placement specified. The number of spine levels is presented by placement of the matrix.
Supplemental Fixation
时间窗: During surgery
The number of spine levels on which supplemental fixation was performed is presented by approaches of stabilization (anterior or posterior stabilization).
次要结局
- The Number of Adverse Events of Interest(12 months)
- The Number of Subjects Having Secondary Spine Surgical Intervention(12 months)
- The Number of Unplanned Secondary Spine Interventions in Subgroups(12 months)
- AEI Categorisation(12 months)
- Fusion Status at the Last Assessment Performed by 12 Months(12 months)
- Fusion Rates in Subgroups(12 months)