Dynamic Stabilization Versus Fusion (DYNORFUSE)

Technical University of Munich

Status

Completed

Conditions

Degeneration of Lumbar Intervertebral Disc

Treatments

Procedure: standard

Procedure: new

Study type

Interventional

Funder types

Other

Identifiers

NCT01365754

DYN-1009-MEY-0000-I

Details and patient eligibility

About

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

Full 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.

Enrollment

440 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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