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OpenTrials
Completed

NCT Number: NCT01365754

Dynamic Stabilization Versus Fusion

The purpose of this study is to compare posterior dynamic stabilization with fusion in the treatment of lumbar degenerative disease.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. Dr. med. Bernhard Meyer

München, 81675, Germany

About this study

Two strategies for treatment of degenerative lumbar instability are in frequent clinical use: fusion versus dynamic stabilization. Up to now it is not clear whether fusion (Gold-standard) or the non-fusion technique is superior. Nevertheless some data are available that dynamic stabilization as a less invasive technique can achieve similar or better results concerning patient satisfaction and re-OP rate compared with fusion as the standard therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years
  • Mono- or bisegmental symptomatic lumbar degenerative disease with or without stenosis
  • Indication for fusion with (i) spondylolisthesis of at least 5mm or segmental vertebral motion of at least 3mm or 10º on flexion/extension radiographs, (ii) predominant low back pain in combination with Modic changes
  • Failure of adequate conservative measures for more than 3 months
  • Correctly signed informed consent form

Exclusion criteria

  • Olisthesis more than grade I, spondylolisthesis vera, spondylolysis without olisthesis or spinal deformity (i.e. scoliosis of more than 20°, sagittal imbalance)
  • Significant comorbidity impeding with surgical success (e.g. osteoporosis, rheumatoid arthritis, mental illness)
  • Previous fusion or stabilization surgery

Treatment and study plan

standard

Procedure

fusion

new

Procedure

dynamic stabilization

Primary outcomes

  1. Difference in Oswestry disability index (ODI) between treatment groups at 2 years post intervention

    Time frame: 2 years after intervention

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

Posterior Dynamic Stabilization Versus Fusion in the Treatment of Lumbar Degenerative Disease

Acronym: DYNORFUSE

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Jun 3, 2011
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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