Multi-center, Prospective, Single Position, Spine Surgery Outcomes Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 234
- 试验地点
- 6
- 主要终点
- Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Intensity
研究概览
简要总结
The purpose of this study is to systematically, prospectively compare surgical fusion techniques for thoracolumbar spinal fusion patients and assess long-term patient outcomes and revision rates following surgery.
详细描述
The goal of this study is to understand how the difference in positioning of a patient intraoperatively, as part of performing an anterior posterior spine fusion surgery, can affect short term and long term outcomes. This will be accomplished through observational techniques that will not affect the care patients will receive for their spinal conditions.
Patients will be asked to complete health and wellness surveys before and after survey to determine how they are doing before surgery and then what if any changes their respective surgeries have had on their lives. Further spine x-rays that they have taken to plan their surgeries and assess their recovery will be measured, when available. X-rays will not be taken only for research purposes. Additionally aspects of their surgeries will be noted such as where hardware is placed and how long different parts of the surgery took.
Follow-up is planned to be out to 10 years post-operatively with the goal of collecting information about any revision spine surgeries that would happen during those 10 years as well.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •Ability to speak and read comfortably in English
- •Affliction by a spinal condition warranting evaluation for operative treatment
排除标准
- •Current incarceration
- •Individuals incapable of consenting and/or objectively responding to surveys, irrespective of reasonable assistance
- •Women currently pregnant or expecting to become pregnant in the near future
- •Subjects participating in another research study, whose protocol would conflict with comprehensive participation in this study
- •Subjects with psychiatric pathology which may impair judgement or the ability to give informed consent.
结局指标
主要结局
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Intensity
时间窗: 10 years
Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Pain Intensity.
Difference in Radiographic Measurements-Pelvic Incidence (PI)
时间窗: 10 years
Assess the difference between pre-op and post-op measurements of PI using available spinal x-rays for patients whose PI was to be changed as part of their surgical plan.
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Interference
时间窗: 10 years
Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Pain Interference.
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Depression
时间窗: 10 years
Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Depression.
Difference in Radiographic Measurements-Cobb Angles
时间窗: 10 years
Assess the difference between pre-op and post-op measurements of Cobb Angles using available spinal x-rays for patients whose Cobb Angle was to be changed as part of their surgical plan.
Difference in Radiographic Measurements-C7 Sagittal Vertical Alignment (SVA)
时间窗: 10 years
Assess the difference between pre-op and post-op measurements of C7 SVA using available spinal x-rays for patients whose C7 SVA was to be changed as part of their surgical plan.
Difference in Radiographic Measurements-Coronal Sagittal Vertical Alignment (SVA)
时间窗: 10 years
Assess the difference between pre-op and post-op measurements of Coronal SVA using available spinal x-rays for patients whose Coronal SVA was to be changed as part of their surgical plan.
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Anxiety
时间窗: 10 years
Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Anxiety.
Difference in Radiographic Measurements-Pelvic Tilt (PT)
时间窗: 10 years
Assess the difference between pre-op and post-op measurements of spinal x-rays for patients whose PT was to be changed as part of their surgical plan.
Difference in Radiographic Measurements-Lumbar Lordosis (LL)
时间窗: 10 years
Assess the difference between pre-op and post-op measurements of spinal x-rays for patients whose LL was to be changed as part of their surgical plan.
Difference in Radiographic Measurements-T1 Pelvic Angle (TPA)
时间窗: 10 years
Assess the difference between pre-op and post-op measurements of spinal x-rays, for patients whose TPA was to be changed as part of their surgical plan.
Revision Incidence
时间窗: 10 years
Determine the incidence of spine surgery revisions after the initial surgery.
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Physical Function Scores
时间窗: 10 years
Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates less Physical Function.
Difference in Radiographic Measurements-Fractional Curve Cobb Angles
时间窗: 10 years
Assess the difference between pre-op and post-op measurements of Fractional Curve Cobb Angles using available spinal x-rays for patients whose Fractional Curve Cobb Angle was to be changed as part of their surgical plan.
次要结局
未报告次要终点