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Patient Reported Outcome After Surgical Treatment of DDD in Scandinavia

NCT02980822 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3500

Last updated 2024-07-30

No results posted yet for this study

Summary

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.

Conditions

  • Spinal Diseases
  • Surgery
  • Degeneration Disc

Sponsors & Collaborators

  • Spine Centre of Southern Denmark

    lead OTHER

Principal Investigators

  • Mikkel Ø Andersen, MD · Sygehus Lilleaelt

Eligibility

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

Timeline & Regulatory

Start
2011-01-01
Primary Completion
2019-01-31
Completion
2019-01-31

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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 NCT02980822 on ClinicalTrials.gov