Status:
UNKNOWN
Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine
Lead Sponsor:
University of Cologne
Conditions:
Spondylolisthesis
Erosive Osteochondrosis in L2-S1
Eligibility:
All Genders
30+ years
Phase:
NA
Brief Summary
Does a new "topping-off" device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability ...
Detailed Description
Primary efficacy endpoint: The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Ph...
Eligibility Criteria
Inclusion
- Key inclusion criteria:
- 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 criteria:
- 1\. Radiological signs of existing instability of the adjacent segment 2. Normal endplates and no disc desiccation in MRI in the adjacent seg-ment 3. Previous surgery of the lumbar spine
- \-
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01224379
Start Date
January 1 2011
End Date
October 1 2012
Last Update
October 20 2010
Active Locations (1)
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1
University of Cologne, Department of Orthopedics& traumasurgery
Cologne, Germany, 50931