An Ambispective Efficacy Evaluation of the Karma Fixation System
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Fusion
研究概览
简要总结
The purpose of this observational, multi-center, ambispective study is collect real world patient outcomes that characterize the effectiveness of the Karma Fixation System in the lumbar spine.
详细描述
This is a multicenter, observational, ambispective study of up to 100 patients across a maximum of 10 US sites. Retrospective data collection will be performed from preoperative up to the single prospective visit. Prospective data collection will include a one-time visit to obtain post-operative imaging. In the event a subject has a complete 12-month data set available retrospectively, the prospective visit may not be required.
PRIMARY ENDPOINTS:
- Fusion status at a minimum of 12-months postoperative (≥10 months post surgery)
SECONDARY ENDPOINTS:
- Procedure-or device-related serious adverse events (SAE)
- Patient reported outcomes if available included, Oswestry Disability Index (ODI), Back and leg pain as measured by Visual Analog Scale (VAS), 12-Item Short Form Health Survey (SF-12)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Skeletally mature and age ≥ 18 years of age at the time of surgery
- •Previously treated with the Karma Fixation System
- •Has at least 12-months post-surgery imaging obtained including a minimum 2 view x-rays (lateral flexion and lateral extension) and CT scan, or willing to return to obtain imaging
- •Be willing and able to comply with the study protocol requirements
- •Be willing to sign the study-specific Informed Consent Document
排除标准
- •Previous fusion or total disc replacement at the index level(s)
- •Active systemic infection at the index level at the time of surgery
- •Current active or suspected malignancy, or a cancer diagnosis that was ongoing during the patient's treatment and healing period
- •Diagnosis of osteomalacia or Paget's bone disease
- •Currently enrolled in a competing research study
- •Currently incarcerated \
- •Currently pregnant or plans to become pregnant
结局指标
主要结局
Fusion
时间窗: 12 month post surgery (≥10 months post surgery)
Fusion at treated levels as measured by x-rays and CT scan.
次要结局
- Change in Disability(Baseline and 12 months post surgery)
- Serious Adverse Events(Surgery through study completion)
- Change in Pain(Baseline and 12 months post surgery)
- Change in Quality of Life(Baseline and 12 months post surgery)