Trial document




drksid header

  DRKS00004832

Trial Description

start of 1:1-Block title

Title

Retrospective comparing fusion rate analysis of a TLIF PEEK cage according to the addressed spinal segments.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

A retrospective analysis of cases treated with a particular spine surgical procedure (TLIF) during 2009 and 2012 either monosegmental in spine level L3/4 or L4/5 or bisegmental in spine levels L3-L5 is done. Fusion rate in operated segments is evaluated in a follow up of 3 years. This is compared in between the operated segments.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

A retrospective analysis of cases treated with a TLIF procedure during 2009 and 2012 either monosegmental in level L3/4 or L4/5 or bisegmental in levels L3-L5 is done. Fusion rate in operated segments is evaluated in a follow up of 3 years. This is compared in between the operated segments.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004832
  •   2013/05/14
  •   [---]*
  •   no
  •   Approved
  •   2013-549N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   [---]* 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Degnerative Discopathie, Postnukleotomiesyndrom, Osteochondrose, Neuroforamenstenose, Spondylolisthesis
  •   M40-M54 -  Dorsopathies
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   A retrospective analysis of cases treated with a TLIF procedure during 2009 and 2012 either monosegmental in level L3/4 bis L4/5 or bisegmental in levels L3 bis L5 is done. Fusion rate in operated segments is evaluated in a follow up of 3 years. This is compared in between the operated segments.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Fusion rate: standarized X-ray of lumbar spine after minimum 6 months post OP

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Oswestry Disability Index (ODI)
Clinical Outcome Measurement (COMI Score)
Patient Sactisfaction Index (PSI)
Minimu 6 months up to 3 years post OP

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/08/15
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- age > 18 years
- male and female
- Surgery done with TLIF monosegmental (L4/5 or L5/S1) or bisegmental (L4-S1)
- degenerative disc desease, postnucleotomy syndrome, spondylosis, neuroforaminal stenosis or spondylolisthesis

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Smoking
- Diabets
- Spondylodiscitis
- Revision Surgery on former TLIF Procedures
- former lumbar interbody fusion in other segments (non L4/5 and L5/S1)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Signus Medizintechnik
    • Carl-Zeiss-Straße 2
    • 63755  Alzenau
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • St. Marienkrankenhaus, Ludwigshafen am Rhein
    • Mr.  Dr. med.  Michael  Breitenfelder 
    • Salzburgerstr. 15
    • 67067  Ludwigshafen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • St. Marienkrankenhaus, Ludwigshafen am Rhein
    • Mr.  Dr. med.  Michael  Breitenfelder 
    • Salzburgerstr. 15
    • 67067  Ludwigshafen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • St. Marienkrankenhaus, Ludwigshafen am Rhein
    • Mr.  Dr. med.  Michael  Breitenfelder 
    • Salzburgerstr. 15
    • 67067  Ludwigshafen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2015/12/09
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.