Dynamic Stabilization Versus Fusion

Not Applicable

Completed

• Conditions: Degeneration of Lumbar Intervertebral Disc
• Interventions: Procedure: standard; Procedure: new

• Registration Number: NCT01365754
• Lead Sponsor: Technical University of Munich

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.

Study Timeline

• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-03
• Study Start: 2011-09
• Primary Completion: 2017-12
• Study Completion: 2018-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-11
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	standard	A - Fusion
B	new	B - Dynamic (new)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Prof. Dr. med. Bernhard Meyer; 🇩🇪 München, Germany