Dynamic Stabilization Versus Fusion

Degeneration of Lumbar Intervertebral Disc Clinical Trial

— DYNORFUSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365754
• Other study ID #: DYN-1009-MEY-0000-I
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: August 2018

Study information

• Verified date: September 2018
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare posterior dynamic stabilization with 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: August 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degeneration of Lumbar Intervertebral Disc
• Intervertebral Disc Degeneration

Intervention

Procedure:
• standard
fusion
• new
dynamic stabilization

Locations

Country	Name	City	State
Germany	Prof. Dr. med. Bernhard Meyer	München

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

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