Pelvic Incidence-Dependent Clustering of Sagittal Spinal Alignment: A Novel Classification to Aid Surgical Planning for Adult Spinal Deformity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proximal Junctional Kyphosis
研究概览
简要总结
Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with adult spinal deformity who underwent correction surgery with reference to our pelvic incidence-dependent (PI-dependent) clustering of sagittal spinal alignment and existing standards (sagittal age-adjusted score [SAAS], global alignment and proportion [GAP] score, and Roussouly classification). Our findings may provide tangible guidance for surgical decision-making in ASD.
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
- Single (Outcomes Assessor)
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
- •≥ 18 years of age at the time of treatment;
- •Complete radiographic data, including standing posteroanterior and lateral whole-spine radiographs, lumbar computed tomography, and lumbar magnetic resonance imaging;
- •Radiographic evidence of ASD: sagittal vertical axis ≥ 50 mm, pelvic tilt ≥ 25°, pelvic incidence-lumbar lordosis mismatch ≥ 10°, and/or thoracic kyphosis ≥ 60°.
排除标准
- •Any type of previous spinal surgery;
- •Other musculoskeletal problems impeding walking ability, syndromic or neuromuscular diseases such as Parkinson's disease, inflammatory conditions such as ankylosing spondylitis, infectious conditions such as spinal tuberculosis, metabolic diseases such as severe osteoporosis, and/or serious general medical conditions such as sepsis or malignancy;
- •Pathology of deformity as follows: post-traumatic deformity, adult idiopathic scoliosis of the thoracic spine, or de-novo lumbar scoliosis;
- •Hip joint Kellgren-Lawrence grade ≥ II, history of hip joint and/or knee joint pain, and/or previous joint replacement.
结局指标
主要结局
Proximal Junctional Kyphosis
时间窗: Two years after surgery
Proximal junctional kyphosis (PJK) was defined by a proximal junctional angle (PJA) (Cobb angle between the superior endplate of UIV+2 and inferior endplate of UIV) of \> 10° and a PJA angle difference of \> 10° from baseline at any time point up to latest follow-up.
次要结局
- Scoliosis Research Society-22(One month, 3 months, 6 months, 1 year, and 2 years after surgery)
- Oswestry disability index(One month, 3 months, 6 months, 1 year, and 2 years after surgery)
- Achievement of minimal clinically important difference(Two years after surgery)