Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 18
- 主要终点
- Veterans RAND 12 Item Health Survey (VR-12)
研究概览
简要总结
Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications.
详细描述
Specific Aims:
• Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications.
a. Complex ASD patients will be defined based upon clinical, radiographic and/or procedural criteria identified in an analysis of the existing ISSG ASD database: i. Magnitude of coronal and/or sagittal spinal deformity ≥75th percentile of patients in the ISSG database.
ii. Clinical or Radiographic parameters that corresponded to patients in the ISSG database that had complications requiring revision spine surgery and/or patients that had hospital length of stay >9 days.
iii. Procedures involving 3 column osteotomies and/or anterior column reconstruction (ACR) of the spine
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
- •Inclusion Criteria:
- •Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity
- •Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)
- •Complex patients are defined as and meeting any one of the subsequent criteria:
- •Radiographic criteria:
- •PI-LL ≥ 25 degrees
- •TPA ≥ 30 degrees
- •SVA>15cm
- •Thoracic scoliosis ≥ 70 degrees
- •Thoracolumbar/lumbar scoliosis ≥ 50 degrees
- •Global coronal malalignment >7cm
- •Procedural criteria:
- •Posterior spinal fusion > 12 levels
- •3 column osteotomy or ACR
- •Geriatric criteria:
- •Age >65 years and minimum 7 levels of spinal instrumentation during surgery
排除标准
- •Age <18 years of age
- •Active spine tumor or infection
- •Deformity due to acute trauma
- •Neuromuscular conditions/diseases (Parkinson's, Multiple Sclerosis, Post-polio syndrome)
- •Syndromic scoliosis
- •Inflammatory arthritis/auto immune diseases (Rheumatoid arthritis, Lupus, Ankylosing Spondylitis)
- •Women who are pregnant
- •Non English speaking patients
研究组 & 干预措施
Operative
A. Multicenter, prospective, nonrandomized analysis of operatively treated complex ASD patients meeting the following Inclusion Criteria
- 18 years of age or greater at the time of treatment
- Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity
- Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)
- Complex patients are defined as and meeting any one of the subsequent criteria:
a. Radiographic criteria: i. PI-LL ≥ 25 degrees ii. TPA ≥ 30 degrees iii. SVA>15cm iv. Thoracic scoliosis ≥ 70 degrees v. Thoracolumbar/lumbar scoliosis ≥ 50 degrees vi. Global coronal malalignment >7cm b. Procedural criteria: i. Posterior spinal fusion > 12 levels ii. 3 column osteotomy or ACR c. Geriatric criteria: i. Age >65 years and minimum 7 levels of spinal instrumentation during surgery
干预措施: Index or spine revision surgery for complex adult spinal deformity (Procedure)
结局指标
主要结局
Veterans RAND 12 Item Health Survey (VR-12)
时间窗: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Patient reported outcome
Patient-Reported Outcome Measurement Information System (PROMIS) - Depression
时间窗: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PRO
Visual Analog Scale - Back Pain
时间窗: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Self-reported back pain on scale of 0 (No pain) to 10 (severe pain)
Scoliosis Research Society (SRS) 22r
时间窗: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Scoliosis specific patient reported outcome
Oswestry Disability Index (ODI)
时间窗: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Spine specific patient reported outcome
Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function
时间窗: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PRO
Visual Analog Scale - Leg Pain
时间窗: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Self-reported leg pain on scale of 0 (No pain) to 10 (severe pain)
Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference
时间窗: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PRO
Radiographic Evaluation
时间窗: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Cobb angles, Coronal \& Sagittal balance, spinopelvic measures
Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
时间窗: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PROs
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role Satisfaction
时间窗: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PRO
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA)
时间窗: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PRO
次要结局
- Canadian Study of Health and Aging (CSHA)(Change from Preop to 3months and 1, 2, 5 & 10 year follow-up)
- Edmonton Frail Scale(Change from Preop to 3months and 1, 2, 5 & 10 year follow-up)
- Adverse Events(3 months and 1, 2, 5 & 10 year post treatment)