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Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine (Topping-off)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by University of Cologne.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01224379
First Posted: October 20, 2010
Last Update Posted: October 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Cologne
October 19, 2010
October 20, 2010
October 20, 2010
January 2011
July 2012   (Final data collection date for primary outcome measure)
SF36 [ Time Frame: 6 Month ]

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).

Same as current
No Changes Posted
  • 1.Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36 [ Time Frame: 6 weeks ]
    1. Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36 follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline
  • Safety [ Time Frame: all time ]

    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
  • Individual dimensions of the Oswestry Disability Index (ODI) [ Time Frame: 6weeks ]
    Individual dimensions of the Oswestry Disability Index (ODI) follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline
  • Time until radiological adjacent instability and comparison to the clinical outcome [ Time Frame: 6 weeks ]
    Time until radiological adjacent instability and comparison to the clinical outcome follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline
  • Capacity of work at the time of surgery and after surgery, time until return to work [ Time Frame: 6 weeks ]
    Capacity of work at the time of surgery and after surgery, time until return to work follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline
Same as current
Not Provided
Not Provided
 
Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine
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
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?

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).

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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Spondylolisthesis
  • Erosive Osteochondrosis in L2-S1
  • Device: 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).
    Other Name: Topping off
  • Device: 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)
  • 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).
    Intervention: Device: Topping off system
  • 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)
    Intervention: Device: monosegmental PLIF
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
October 2012
July 2012   (Final data collection date for primary outcome measure)

Key inclusion criteria:

  1. Male or female >30 years of age
  2. Lumbar spine pathology with indication for monosegmental PLIF
  3. 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

Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01224379
Uni-Köln-1223
Uni-Köln-1223 ( Other Grant/Funding Number: University of Cologne )
Yes
Not Provided
Not Provided
University of Cologne, Medizinische Fakultät der Universität zu Köln
University of Cologne
Not Provided
Principal Investigator: Jan Siewe, Dr. University of Cologne
University of Cologne
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP