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

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ClinicalTrials.gov Identifier: NCT01224379
Recruitment Status : Unknown
Verified September 2010 by University of Cologne.
Recruitment status was:  Not yet recruiting
First Posted : October 20, 2010
Last Update Posted : October 20, 2010
Sponsor:
Information provided by:
University of Cologne

Tracking Information
First Submitted Date  ICMJE October 19, 2010
First Posted Date  ICMJE October 20, 2010
Last Update Posted Date October 20, 2010
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2010)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine
Official Title  ICMJE 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
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?
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 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spondylolisthesis
  • Erosive Osteochondrosis in L2-S1
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 19, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2012
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01224379
Other Study ID Numbers  ICMJE Uni-Köln-1223
Uni-Köln-1223 ( Other Grant/Funding Number: University of Cologne )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Cologne, Medizinische Fakultät der Universität zu Köln
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jan Siewe, Dr. University of Cologne
PRS Account University of Cologne
Verification Date September 2010

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