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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Cologne.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT01224379
First received: October 19, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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 Intervention
Spondylolisthesis
Erosive Osteochondrosis in L2-S1
Device: Topping off system
Device: monosegmental PLIF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • SF36 [ Time Frame: 6 Month ] [ Designated as safety issue: No ]

    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.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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other Name: monosegmental PLIF

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
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224379

Contacts
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
Germany
University of Cologne, Department of Orthopedics& traumasurgery Not yet recruiting
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
Principal Investigator: Jan Siewe, Dr. University of Cologne
  More Information

Additional Information:
No publications provided by University of Cologne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Cologne, Medizinische Fakultät der Universität zu Köln
ClinicalTrials.gov Identifier: NCT01224379     History of Changes
Other Study ID Numbers: Uni-Köln-1223, Uni-Köln-1223
Study First Received: October 19, 2010
Last Updated: October 19, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Cologne:
Lumbar spine
fusion
adjacent instability
topping-off.

Additional relevant MeSH terms:
Osteochondrosis
Spondylolisthesis
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis
Spinal Diseases

ClinicalTrials.gov processed this record on July 31, 2014