Dynamic Stabilization Versus Fusion

Posterior Dynamic Stabilization Versus Fusion in the Treatment of Lumbar Degenerative Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01365754

Acronym

DYNORFUSE

Enrollment

440

Registered

2011-06-03

Start date

2011-09-30

Completion date

2018-08-31

Last updated

2018-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degeneration of Lumbar Intervertebral Disc

Keywords

Lumbar degenerative disease

Brief summary

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

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.

Interventions

PROCEDUREstandard

fusion

PROCEDUREnew

dynamic stabilization

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026