MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,000
- 试验地点
- 4,397
- 主要终点
- Rate of surgical, minimally invasive intervention.
研究概览
简要总结
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor.
详细描述
In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46) and does not require prior enrollment nor patient consent. The inclusion of the study's NCT number on MILD Medicare claims is required and results in enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Medicare beneficiaries receiving MILD or interspinous process decompression
- •Diagnosis of LSS with NC
排除标准
- •Patients that have received a laminectomy, laminotomy, fusion, interspinous process decompression, or MILD in the lumbar region during the 12 months prior to the index date
研究组 & 干预措施
MILD
All Medicare patients treated with MILD as reported via CPT® Code 0275T or successor codes (62330/62331).
干预措施: MILD (Device)
Interspinous Process Decompression
All Medicare patients treated with interspinous process decompression (CPT Code 22869 or 22870, or successor code(s)) for the treatment of LSS with NC.
干预措施: Interspinous Process Decompression (Device)
结局指标
主要结局
Rate of surgical, minimally invasive intervention.
时间窗: 24 months
Measure the rate of Medicare beneficiary surgical and minimally invasive intervention for LSS with NC post index procedure.
Rate of participants with harms associated with the index procedure
时间窗: 24 months
Rate of participants with harms associated with the index procedure including, but not limited to, revisions, displacement, mechanical complications, and death. Complications will be counted if they are recorded during the index hospitalization, or any rehospitalization within 30 days of discharge.
次要结局
未报告次要终点