Dynamic Stabilization Versus Fusion
This trial is active, not recruiting.
|Condition||degeneration of lumbar intervertebral disc|
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
A - Fusion
B - Dynamic (new)
Difference in Oswestry disability index (ODI) between treatment groups at 2 years post intervention
time frame: 2 years after intervention
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
|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.|
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