This trial is active, not recruiting.

Condition degeneration of lumbar intervertebral disc
Treatments standard, new
Sponsor Technische Universität München
Start date September 2011
End date July 2017
Trial size 440 participants
Trial identifier NCT01365754, DYN-1009-MEY-0000-I


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
(Active Comparator)
A - Fusion
(Active Comparator)
B - Dynamic (new)
dynamic stabilization

Primary Outcomes

Difference in Oswestry disability index (ODI) between treatment groups at 2 years post intervention
time frame: 2 years after intervention

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Posterior Dynamic Stabilization Versus Fusion in the Treatment of Lumbar Degenerative Disease
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Technische Universität München.