Outcome of Surgery for Sciatica - a Comparison of Data From Three National Quality Registries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 7,500
- Primary Endpoint
- Oswestry disability index
Study Overview
Brief Summary
Purpose: The incidence of surgery for lumbar disc hernia varies. According to the national spine registries in Sweden, Norway and Denmark, there is a 30-60% 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 hernia 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, we will compare baseline data, indications for surgery and patient reported outcome one year after surgery for lumbar disc herniation. 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.
Detailed Description
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 lumbar disc herniation 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%.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients treated with surgery for lumbar disc herniation in Denmark, Sweden or Norway and registered in a national quality register.
Exclusion Criteria
- •Patients not treated with discectomy for the lumbar disc herniation.
Outcomes
Primary Outcomes
Oswestry disability index
Time Frame: preoperative and 1 year postoperative
Index at baseline, index change from preoperative to 1 year follow-up and actual index at 1 year follow-up. Oswestry disability index version 2.1 (from 0; no disability to 100; maximum disability)
Secondary Outcomes
- EQ-5D(preoperative and 1 year postoperative)
- Return to work rate(Preoperative work rate. Work rate at the 1 year follow-up.)
- Numerical rating scale for back pain(preoperative and 1 year postoperative)
- Additional surgery in the same segment of the lumbar spine(During the 1 year follow-up)
- Numerical rating scale for leg pain(preoperative and 1 year postoperative)
Investigators
Paul Gerdhem
MD, PhD, Assoc Prof
Karolinska Institutet