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Dynamic Stabilization Versus Fusion (DYNORFUSE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01365754
First Posted: June 3, 2011
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Technische Universität München
  Purpose
The purpose of this study is to compare posterior dynamic stabilization with fusion in the treatment of lumbar degenerative disease.

Condition Intervention
Degeneration of Lumbar Intervertebral Disc Procedure: standard Procedure: new

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Posterior Dynamic Stabilization Versus Fusion in the Treatment of Lumbar Degenerative Disease

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Difference in Oswestry disability index (ODI) between treatment groups at 2 years post intervention [ Time Frame: 2 years after intervention ]

Estimated Enrollment: 440
Study Start Date: September 2011
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
A - Fusion
Procedure: standard
fusion
Active Comparator: B
B - Dynamic (new)
Procedure: new
dynamic stabilization

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365754


Locations
Germany
Prof. Dr. med. Bernhard Meyer
München, Germany, 81675
Sponsors and Collaborators
Technische Universität München
  More Information

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01365754     History of Changes
Other Study ID Numbers: DYN-1009-MEY-0000-I
First Submitted: June 1, 2011
First Posted: June 3, 2011
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by Technische Universität München:
Lumbar degenerative disease

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases