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Outcome of Surgery for Sciatica - a Comparison of Data From Three National Quality Registries

NCT02889484 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7500

Last updated 2017-12-05

No results posted yet for this study

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.

Conditions

  • Intervertebral Disc Displacement
  • Sciatica

Interventions

PROCEDURE

Lumbar disc hernia surgery

Sponsors & Collaborators

Principal Investigators

  • Paul Gerdhem, MD, PhD · Karolinska University Hospital and Karolinska Institutet, K54, Huddinge, SE-141 86 Stockholm, Sweden

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-12-31
Completion
2015-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02889484 on ClinicalTrials.gov