Status:
TERMINATED
Efficacy of Hybrid Systems in Comparison to the Rigid Spondylodesis in Lumbar-spine Fusion
Lead Sponsor:
University of Cologne
Conditions:
Spondylolisthesis
Eligibility:
All Genders
30+ years
Phase:
NA
Brief Summary
This study is designed as a randomized, parallel-group, therapy-controlled trial in a clinical care setting at a university hospital. Patients presenting to our outpatient clinic with degenerative dis...
Detailed Description
Patients over 30 years of age presenting to our outpatient clinic with degenerative disc disease or spondylolisthesis and indications for monosegmental lumbar spine fusion are eligible for trial inclu...
Eligibility Criteria
Inclusion
- Key-
- Male or female \>30 years of age
- Lumbar spine pathology with indication for monosegmental PLIF
- Radiological signs of a degeneration of the adjacent segment without instability
- Key
Exclusion
- Radiological signs of existing instability of the adjacent segment
- Normal endplates and no disc desiccation in MRI in the adjacent seg-ment
- Previous surgery of the lumbar spine
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01852526
Start Date
March 1 2013
End Date
July 1 2017
Last Update
September 16 2015
Active Locations (2)
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1
University hospital, Department of orthopedics & traumasurgery
Cologne, North Rhine-Westphalia, Germany, 50924
2
University hospital, Department of orthopedics
Halle, Saxony-Anhalt, Germany, 06112