Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
440 participants
INTERVENTIONAL
2011-09-30
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
A - Fusion
standard
fusion
B
B - Dynamic (new)
new
dynamic stabilization
Interventions
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standard
fusion
new
dynamic stabilization
Eligibility Criteria
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Inclusion Criteria
* 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
* Significant comorbidity impeding with surgical success (e.g. osteoporosis, rheumatoid arthritis, mental illness)
* Previous fusion or stabilization surgery
18 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Locations
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Prof. Dr. med. Bernhard Meyer
München, , Germany
Countries
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Other Identifiers
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DYN-1009-MEY-0000-I
Identifier Type: -
Identifier Source: org_study_id
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