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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

Study Description
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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?

Condition or disease Intervention/treatment Phase
Spondylolisthesis Erosive Osteochondrosis in L2-S1 Device: Topping off system Device: monosegmental PLIF Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : October 2012
Arms and Interventions
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Arm Intervention/treatment
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).
 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
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)
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224379


Contacts
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Contact: Jan Siewe, Dr. +49-221-478-87294 studienzentrum-ortho-unfall@uk-koeln.de
Contact: Margarete Wicharz +49-221-478-87294 studienzentrum-ortho-unfall@uk-koeln.de

Locations
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Germany
University of Cologne, Department of Orthopedics& traumasurgery
Cologne, Germany, 50931
Contact: Jan Siewe, Dr.    +49-221-478-87294    studienzentrum-ortho-unfall@uk-koeln.de   
Principal Investigator: Jan Siewe, Dr.         
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Jan Siewe, Dr. University of Cologne
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Cologne, Medizinische Fakultät der Universität zu Köln
ClinicalTrials.gov Identifier: NCT01224379    
Other Study ID Numbers: Uni-Köln-1223
Uni-Köln-1223 ( Other Grant/Funding Number: University of Cologne )
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: October 20, 2010
Last Verified: September 2010
Keywords provided by University of Cologne:
Lumbar spine
fusion
adjacent instability
topping-off.
Additional relevant MeSH terms:
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Spondylolisthesis
Osteochondrosis
Spondylolysis
Spondylosis
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases