Single Institution Prospective Analysis of an Enhanced Recovery After Complex Spine Surgery Protocol
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Length of Stay
研究概览
简要总结
In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. This study will evaluate the efficacy of an Enhanced Recovery After Surgery protocol for complex spine surgery performed for the treatment of ASD.
详细描述
Purpose : In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. This study will evaluate the efficacy of an Enhanced Recovery After Surgery protocol for complex spine surgery performed for the treatment of ASD.
Participants : Patients undergoing surgery aimed at treating adult spinal deformity are the subject of this research. This population was chosen as these procedures are often associated with prolonged length of stay (LOS), high post-operative narcotic use, and often require complex post-operative discharge planning.
Procedures : Patients undergoing surgery to address the complications of ASD present a unique challenge in that this patient population is diverse, and there are multiple operative procedures available to treat the same condition. Given that there are currently no accepted or recommended Enhanced Recovery After Surgery protocols for complex spine procedures, the investigators have developed an ERAS protocol at the University of North Carolina (UNC) in collaboration with the anesthesia department for the support of complex surgical patients.
Hypothesis
Implementing a multi-modal enhanced recovery after complex spine surgery protocol will improve patient measured outcomes and patient functional outcomes leading to a statistically significant reduction in LOS, post-operative pain, complication rate, cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with a diagnosis of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) Scoliosis (M41.9) category.
- •Patients undergoing a > 5 level arthrodesis using one of the following Current Procedural Terminology (CPT) coded procedures 22534, 22585, 22614, 22632, 22634 with either 22842, 22853
- •Cobb angle > 10 degrees
- •Failure of 3 months of conservative management
排除标准
- •Prior scoliosis surgery not performed at UNC Chapel Hill Hospital Facilities
- •Deformity correction due to trauma
- •History of neoplastic spine disease
- •Patients with active osteomyelitis
- •Patients with prior cement augmentation.
结局指标
主要结局
Length of Stay
时间窗: From conclusion of surgery to hospital discharge, an expected average of 10 days
Number of nights spent in the hospital following surgery
次要结局
- Change in Oswestry Disability Index Score from Pre-op baseline.(Preop to post op comparison of ODI at 4 days, 2 weeks, 6 weeks, 12 weeks and 6 months.)
- Promis Score - Physical Function(Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.)
- Change in Thoracic Kyphosis (TK)(Within 6 months pre-operatively and up to 6 months postoperatively)
- Change in Lumbar Lordosis (LL)(Within 6 months pre-operatively and up to 6 months postoperatively)
- 30 Day Readmission(From day of hospital discharge to 30 days)
- Time to mobilization(From the end of surgery until the date of hospital discharge, assessed up to 1 month.)
- Change in Sagittal Vertical Axis (SVA) Measurement(Within 6 months pre-operatively and up to 6 months postoperatively)
- 90 Day Readmissions(From day of hospital discharge to 90 days)
- 30 Day Reoperations(From day of hospital discharge to 30 days)
- Promis Score - Physical Activity(Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.)
- Narcotic usage(From conclusion of surgery to 12 months)
- Time to oral intake(From the end of surgery until the date of oral intake, assessed up to 2 weeks.)
- Change in Pelvic Tilt (PT)(Within 6 months pre-operatively and up to 6 months postoperatively)
- Promis Score - Pain(Preop to post op comparison of PROMIS instruments at 6 weeks and 6 months.)
- Change in Sacral Slope (SS)(Within 6 months pre-operatively and up to 6 months postoperatively)
- Change in Pelvic Incidence (PI)(Within 6 months pre-operatively and up to 6 months postoperatively)
- Change in Coronal Imbalance Measurement(Within 6 months pre-operatively and up to 6 months postoperatively)
- Change in Coronal Cobb Angle(Within 6 months pre-operatively and up to 6 months postoperatively)
- Change in Degrees of Apical Vertebra Rotation(Within 6 months pre-operatively and up to 6 months postoperatively)