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Dynamic Stabilization Versus Fusion (DYNORFUSE)

This study is currently recruiting participants.
Verified December 2012 by Technische Universität München
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01365754
First received: June 1, 2011
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Posterior Dynamic Stabilization Versus Fusion in the Treatment of Lumbar Degenerative Disease

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: September 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: November 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365754

Contacts
Contact: Bernhard Meyer, Prof. Dr. +49-89-4140-2151 bernhard.meyer@lrz.tu-muenchen.de

Locations
Germany
Prof. Dr. med. Bernhard Meyer Recruiting
München, Germany, 81675
Contact: Bernhard Meyer, Prof. Dr. med.     +49 89 4140-2151     bernhard.meyer@lrz.tu-muenchen.de    
Principal Investigator: Bernhard Meyer, Prof. Dr. med.            
Sponsors and Collaborators
Technische Universität München
  More Information

No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01365754     History of Changes
Other Study ID Numbers: DYN-1009-MEY-0000-I
Study First Received: June 1, 2011
Last Updated: December 10, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
Lumbar degenerative disease

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

ClinicalTrials.gov processed this record on May 23, 2013