Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Performance Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 6
- 主要终点
- Secondary Surgical Interventions (SSIs)
研究概览
简要总结
Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.
详细描述
This study will evaluate the use and performance of the Curvafix IM intramedullary system for pelvic fixation in a post-market setting. Study participants will undergo follow-up care per institutional practice and data will then be collected from participant medical records. There will be no active patient participation requirements outside of standard of care. Any follow up evaluations will be documented and reported through 6 months post-implantation. The study will evaluate secondary surgical interventions as a primary study endpoint. Data will also be collected and analyzed for pelvic reduction stability, fracture healing, participant mobility/ambulation, and general health economics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject, or their Authorized Representative, is willing and able to provide written informed consent, including authorization to release health information
- •Subject has undergone pelvic or acetabular fixation using the IM Implant and the IM Implant was placed according to the manufacturer's labeling.
- •Subject's pelvic or acetabular fixation with the IM Implant occurred within the last 30 calendar days.
排除标准
- •Subject is unwilling or unable to provide written informed consent and/or does not have an authorized representative who can provide consent on their behalf
- •Subject presents with any condition or situation which, in the Investigator's opinion, puts the Subject at risk, could confound the study results, or may interfere with the Subject's participation in the study
结局指标
主要结局
Secondary Surgical Interventions (SSIs)
时间窗: 6 months post-implantation
Performance will be evaluated based upon the number of Secondary Surgical Interventions (SSIs) that occur within the subject's participation as identified through a review of subject medical records.
次要结局
- Pelvic Reduction Stability(6 months post-implantation)
- Mobility(6 months post-implantation)
- Health Economics(6 months post-implantation)