Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine
NCT ID: NCT01224379
Last Updated: 2010-10-20
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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UNKNOWN
NA
30 participants
INTERVENTIONAL
2011-01-31
2012-10-31
Brief Summary
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Detailed Description
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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 Physical Component Summary (PCS).
Key secondary endpoint(s):
1. Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36
2. Individual dimensions of the Oswestry Disability Index (ODI)
3. Time until radiological adjacent instability and comparison to the clinical outcome
4. Capacity of work at the time of surgery and after surgery, time until return to work
Assessment of safety:
1. Treatment complication in control and intervention groups (SAE-management)
2. A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm1: "topping off" system
The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).
Topping off system
The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).
Arm 2: monosegmental PLIF
The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)
monosegmental PLIF
The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)
Interventions
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Topping off system
The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).
monosegmental PLIF
The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Lumbar spine pathology with indication for monosegmental PLIF
3. Radiological signs of a degeneration of the adjacent segment without instability
Exclusion Criteria
\-
30 Years
ALL
No
Sponsors
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University of Cologne
OTHER
Responsible Party
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Medizinische Fakultät der Universität zu Köln
Principal Investigators
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Jan Siewe, Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Cologne
Locations
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University of Cologne, Department of Orthopedics& traumasurgery
Cologne, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Siewe J, Otto C, Knoell P, Koriller M, Stein G, Kaulhausen T, Eysel P, Zarghooni K, Franklin J, Sobottke R. Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2011 Oct 18;12:239. doi: 10.1186/1471-2474-12-239.
Related Links
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Related Info
Other Identifiers
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Uni-Köln-1223
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Uni-Köln-1223
Identifier Type: -
Identifier Source: org_study_id