Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine
Topping-off
Clinical Trial of the Efficacy of Hybrid Systems(Topping Off)in Comparison to the Conventional Spondylodesis in Fusion-surgery in the Lumbal Spine: a Prospective, Randomised Study
1 other identifier
interventional
30
1 country
1
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 correlate with clinical outcome?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2010
CompletedFirst Posted
Study publicly available on registry
October 20, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 20, 2010
September 1, 2010
1.5 years
October 19, 2010
October 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SF36
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 Physical Component Summary (PCS).
6 Month
Secondary Outcomes (5)
1.Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36
6 weeks
Safety
all time
Individual dimensions of the Oswestry Disability Index (ODI)
6weeks
Time until radiological adjacent instability and comparison to the clinical outcome
6 weeks
Capacity of work at the time of surgery and after surgery, time until return to work
6 weeks
Study Arms (2)
Arm1: "topping off" system
OTHERThe 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
OTHERThe control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)
Interventions
The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).
The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cologne, Department of Orthopedics& traumasurgery
Cologne, 50931, Germany
Related Publications (1)
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.
PMID: 22008088DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Siewe, Dr.
University of Cologne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 19, 2010
First Posted
October 20, 2010
Study Start
January 1, 2011
Primary Completion
July 1, 2012
Study Completion
October 1, 2012
Last Updated
October 20, 2010
Record last verified: 2010-09