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Outcome of Surgery for Lumbar Spinal Stenosis - a Comparison of Data From Three National Quality Registries

NCT02897947 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7500

Last updated 2018-09-05

No results posted yet for this study

Summary

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.

Conditions

  • Spinal Stenosis
  • Intermittent Claudication

Interventions

PROCEDURE

Surgery for lumbar spinal stenosis in Norway

PROCEDURE

Surgery for lumbar spinal stenosis in Sweden

Surgery for neurogenic claudication due to lumbar spinal stenosis in Sweden

PROCEDURE

Surgery for lumbar spinal stenosis in Denmark

Surgery for neurogenic claudication due to lumbar spinal stenosis in Denmark

Sponsors & Collaborators

Principal Investigators

  • Greger Lønne, md phd · St. Olavs Hospital

Eligibility

Min Age
50 Years
Max Age
90 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 NCT02897947 on ClinicalTrials.gov