Post-Market Data Collection for Biologically Assisted Core Decompression of the Femoral Head Using the PerFuse Instrument and BioCUE
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Harris Hip Score
研究概览
简要总结
This study will evaluate the performance of biologically assisted core decompression with the PerFuse instrument and BioCUE in patients with bone lesions in the femoral head. The study will explore the potential impact of patient demographics and baseline characteristics on post-operative outcomes.
详细描述
This study will evaluate the performance of biologically assisted core decompression with the PerFuse instrument and BioCUE in patients with bone lesions in the femoral head. The study will explore the potential impact of patient demographics and baseline characteristics on post-operative outcomes. The study will evaluate change in Harris Hip Score (HHS) at 12 months after treatment. The change in AVN lesion size will also be measured at 12 months after index treatment via MRI. Change in quality of life and pain measures will be measured at each follow-up. Adverse events will also be recorded throughout the study.
This study will follow patients for 5 years after initial treatment.
Data will be recorded in a online database that will be entered by the site or patient, depending on the report form. This database includes data checks to compare entered data against predefined rules for range.
A risk-based monitoring plan will be put in place for source data verification.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Willing and able to comply with the study procedures
- •Signed informed consent
- •Untreated unilateral or bilateral bone lesion(s) of the femoral head associated with AVN in need of biologically assisted core decompression. Note:If bilateral untreated bone lesions of the femoral head associated with AVN,both hips eligible and willing to undergo study treatment and follow-up
- •≥ 3 months after arthroplasty (e.g., total, hemi) in the contralateral hip
排除标准
- •Pregnant or lactating
- •Participating in another device or drug study
- •ARCO stage ≥ III
- •Unable to undergo MRI of the study hip(s)
- •Active, local or systemic infection
结局指标
主要结局
Harris Hip Score
时间窗: 12 month
Percentage of patients achieving clinical success at 12 month follow up, being defined as a 20 point increase in the Harris Hip Score from baseline
次要结局
- Hips with no lesion size change(12 months)
- Incidence of invasive non-study procedures in the hip(5 years (all time points))
- Second procedure(5 years (all time points))
- Harris Hip Score(5 years (all time points))
- EQ-5D-3L(5 years (all time points))
- NRS Pain(5 years (all time points))
- Adverse Events(5 years (all time points))