Global Coronal Malalignment in Degenerative Lumbar Scoliosis and Priority-Matching Correction Technique to Prevent Postoperative Coronal Decompensation
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
- Oswestry disability index
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 degenerative lumbar scoliosis (DLS) who underwent correction surgery with reference to our priority-matching correction technique and the standard reported by Obeid and colleagues. Our findings may provide tangible guidance for surgical decision-making in DLS.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of DLS based on radiography and previous medical record,
- •Age > 50 years
排除标准
- •Leg length discrepancy,
- •A history of spinal or pelvic surgery,
- •A history of neuromuscular diseases, arthritis or tumor.
研究组 & 干预措施
DLS patients undergoing correction surgery in reference to our novel criteria
Correcting deformity according to the priority-matching correction technique.
干预措施: Priority-matching correction technique in DLS (Procedure)
DLS patients undergoing correction surgery in reference to Obeid classification
Correcting deformity according to the standard proposed by Obeid and colleagues.
干预措施: Traditional correction technique in DLS (Procedure)
结局指标
主要结局
Oswestry disability index
时间窗: One month, 3 months, 6 months, 1 year, and 2 years after surgery
The validated ODI is a self-administered questionnaire for evaluating back-specific functional disability, consisting of 10 items with scores from 0 to 5, and higher ODI indicates more severe disability.
Achievement of minimal clinically important difference
时间窗: Two years after surgery
A prespecified MCID of 10 points was used for the ODI. The minimum clinically important difference (MCID) values for the SRS-22r based on data from a Japanese cohort have previously been reported as follows: function = 0.90, pain = 0.85, self-image = 1.05, mental health = 0.70, and subtotal = 1.05.
Scoliosis Research Society-22
时间窗: One month, 3 months, 6 months, 1 year, and 2 years after surgery
The 22-item SRS-22r questionnaire is specific to scoliosis-related patient-reported outcomes, and consists of 6 domains: function, pain, self-image, mental health, satisfaction, and subtotal, with each domain being scored from 1 to 5 where higher scores correspond to better patient outcomes.
次要结局
未报告次要终点