Dynamic Stabilization Versus Fusion

Technical University of Munich440 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

440

Conditions

Degeneration of Lumbar Intervertebral Disc

Interventions

standardPROCEDURE

fusion

newPROCEDURE

dynamic stabilization

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Prof. Dr. med. Bernhard Meyer

München, Germany

Outcomes

Primary Outcomes

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

Time frame: 2 years after intervention

Data from ClinicalTrials.gov

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