Outcome of Surgery for Lumbar Spinal Stenosis - a Comparison of Data From Three National Quality Registries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7,500
- 主要终点
- Oswestry disability index version 2.1
研究概览
简要总结
There is no international consensus on evaluation and surgical treatment of Lumbar Spinal Stenosis (LSS). The indication for operative treatment is relative, and the variation in surgical rates and procedures is significant, both within and between countries. Understanding practice-based variety is critical since these differences may reflect a disparity in quality of the health care in different institutions, regions, or countries. Norway, Sweden, and Denmark do all have National spine registers for research and quality assessment. Comparing indications for surgery, selected procedure, patient reported outcomes, and factors predicting outcome after surgery for LSS between these countries could provide information about optimal indications and strategy for surgery. Register-based studies have advantages such as large sample sizes and high external validity, but also limitations such as lower follow-up rates, and inferior data quality compared to clinical trials.
Hypotheses: Between these three countries, there are no differences in (i) indications for surgery, (ii) patient-reported outcome after surgery or (iii) risk factors associated to outcome are similar.
详细描述
This is an observational register based study, i.e. prospective data registration and a retrospective study design. Eligible patients are those 50 years or older treated surgically for LSS in Denmark, Norway or Sweden during 2011, 2012, or 2013 with no history of previous lumbar spine surgery. Register-based studies have advantages such as large sample sizes and greater external validity, but also limitations such as lower follow-up rates, inferior data quality compared to clinical trials. Data will be presented according to the STROBE criteria.
The registers:
All registries have the aim of studying outcome after spine surgery. All departments participate voluntarily. Patients participate voluntarily after signing an informed consent. At the time of admission, the patient reports data on demographics, social factors, comorbidity and previous surgery. After surgery, the surgeon records diagnosis and type of surgery performed.
The Norwegian Spine register, NORspine, is based on experiences from the Swespine register and previous validation studies from a local clinical registry, and was founded in 2007. In total 38 of 40 centers performing lumbar spine surgery in Norway report to NORspine. Coverage is approximately 95%. The completeness is approximately 65%.
The Swespine Register has included individuals treated with surgery for lumbar spinal stenosis since 1993. During the last decade, the number of departments participating in the registry has varied between 35 and 41 of the 42 to 45 departments providing spinal surgery services in Sweden. Coverage is approximately 90%. The completeness (number of patients reported to Swespine at the time of surgery) is approximately 80%.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treated with surgery for lumbar spinal stenosis in Norway, Sweden or Denmark
- •registered in a national quality register
- •signed informed consent
排除标准
- •not treated with decompression with or without concomitant arthrodesis for the lumbar spinal stenosis
结局指标
主要结局
Oswestry disability index version 2.1
时间窗: preoperative and 1 year postoperative
(from 0; no disability to 100; maximum disability) Index at baseline, index change from preoperative to 1year follow-up and actual index at 1 year follow-up.
次要结局
- Additional surgery in the lumbar spine(during 1 year follow-up)
- Numerical rating scale for leg pain (from 0; no pain to 10; maximum pain)(preoperative and 1 year postoperative)
- Operation method: Decompression with or without concomitant arthrodesis for the lumbar spinal stenosis.(preoperative)
- Numerical rating scale for back pain (from 0; no pain to 10; maximum pain)(preoperative and 1 year postoperative)
- European Quality of Life-5 Dimensions (EQ-5D) according to the British tariff (UK-time tradeoff, TTO); from -0.59; worst possible health to 1; perfect health)(preoperative and 1 year postoperative)
- Return to work rate(preoperative and 1 year postoperative)