Comparison of Baseline Characteristics and Patient Reported Outcome After Surgical Treatment of Degenerative Lumbar Disc Disease in Scandinavia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,500
- 主要终点
- Change in Oswestry disability index version 2.1 (from 0; no disability to 100; maximum disability)
研究概览
简要总结
Purpose: The incidence of surgery for Degenerative lumbar Disc Disease (DDD). According to the national spine registries in Sweden, Norway and Denmark, there is a difference in surgical incidence between these countries. The cause for this difference is not known. It may reflect a difference in incidence of lumbar disc hernia, but with a similar socio-economic and ethnical background in these countries, it is more likely that the differences are due to varying surgical indications. Comparing indications for surgery, patient reported outcome and factors predictive for outcome after surgery for lumbar disc decease in these countries could provide information about optimal indications for surgery.
Hypotheses: (i) there are no differences in patient-reported outcome after surgery between these countries, (ii) there are no differences in indications for surgery between these countries and (iii), factors that predict outcome are similar in these countries.
Method of research: By using data from three Nordic national spine registers, investigators will compare baseline data, indications for surgery and patient reported outcome one year after surgery for lumbar disc decease. Register based studies have advantages such as large sample sizes, reflecting real life, but they also have limitations such as lower follow-up rates than clinical trials. A non-response analysis will be performed to take this into account.
详细描述
This is an observational register based study, with prospective data registration and a retrospective study design. Included are individuals treated surgically for a lumbar disc herniation between the ages of 18 through 65 years, without a history of previous lumbar spine surgery. Surgery has been performed in Denmark, Norway or Sweden during 2011, 2012 or 2013. Data will be presented according to the STROBE criteria.
The registers
All registries have the aim of studying outcome after spine surgery. All departments and patients participate voluntarily. At the time of admission, the patient reports data consisting of information on social factors, comorbidity and previous surgery. After surgery, the surgeon records diagnosis and type of surgery performed.
The Swespine Register has included individuals treated with surgery for DDD 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%.
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 36 of 40 centers performing lumbar spine surgery in Norway report to NORspine. Coverage is approximately 90%. The completeness is approximately 65%.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients operated due to DDD in the Scandinavian countries during 2011, 2012 or 2013
排除标准
- •No history of previous lumbar spine surgery.
结局指标
主要结局
Change in Oswestry disability index version 2.1 (from 0; no disability to 100; maximum disability)
时间窗: Baseline and 1 year postoperative
次要结局
- Additional surgery in the same segment of the lumbar spine(During 1 year)
- Numerical rating scale for leg pain (from 0; no pain to 10; maximum pain) . The numerical rating scale is used in Norway. The visual analogue scale (0-100) used in Sweden and Denmark will be converted to the numerical rating scale.(Baseline and 1 year postoperative)
- EQ-5D according to the British tariff (UK-TTO; from -0.59; worst possible health to 1; perfect health).(baseline and 1 year postoperative)
- Return to work rate(Baseline and 1 year postoperative)
研究者
Karen Højmark Hansen
Research Nurse, Head of the national DaneSpine office
Spine Centre of Southern Denmark