Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00006034

Trial Description

start of 1:1-Block title

Title

Feasibility Evaluation of the LimiFlex Spinal Stabilization System in the Treatment of Degenerative Spondylolisthesis

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

http://keine/none

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

Brief Summary in Lay Language

Spinal decompression surgery is performed to relieve pressure on nerve roots in the lumbar spine. Surgical spinal decompression is very effective at resolving the back, leg and hip pain caused by spinal stenosis.
All decompression surgeries involve a resection of dorsal spinal structures which may result in varying degrees of flexion instability. We used the spinal stabilisation system LimiFlex to reduce that flexion instability. We are going to do follow up for 24 months in order to measure the pain level and the disability index.

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

Brief Summary in Scientific Language

Patients who present with leg pain caused by spinal canal stenosis can also present with a complaint of activity related back pain. This can be related to the stenosis itself, and other times caused directly by the degenerative changes of the segment. These patients are typically treated with decompression and spinal fusion. While decompression alone can result in significant instability of the treated segment and subsequent restenosis, early fusion may facilitate early degeneration and stenosis of the adjacent levels. The spinal stabilization system LimiFlex (Simpirica Spine Inc, CA, USA) has been developed to limit flexion of the segment, thereby reducing forces borne by the disc, addressing the low back pain and stabilizing segments without the need for fusion.
The LimiFlex deviceis going to be placed after decompression was completed on the treated level. After 3,6,12, and 24 month patient follow ups will be done evaluating patient pain level and the disability index.

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

Organizational Data

  •   DRKS00006034
  •   2014/04/30
  •   [---]*
  •   yes
  •   Approved
  •   09/2470, Freiburger Ethik-Kommission International
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

  •   M48.07 -  [generalization M48.0: Spinal stenosis]
  •   M43.17 -  [generalization M43.1: Spondylolisthesis]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   dorsal decompression and spinal stabilisation with LimiFlex
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   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

Painlevel measured by visual analogue scale and function measured by oswestry disability index after 3, 6, 12 and 24 months

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

Secondary Outcome

[---]*

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

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/12/03
  •   63
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

diagnosis of advanced stenosis of the lumbar spinal canal with or without additional degenerative spondylolisthesis grade 1-2.

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

Exclusion Criteria

Patients who are allergic or intolerant to titanium and/or polyethylene and patients with tumors, infections, severe osteoporosis or other conditions that make appropriate fixation of the implant impossible, women who are pregnant or planning a pregnancy

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Orthopädie und Unfallchirugie Unversitätsklinikum Bonn
    • Mr.  PD Dr.  Robert  Pflugmacher 
    • Sigmund Freud Str. 25
    • 53127  Bonn
    • 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
    • Orthopädie und Unfallchirurgie Univeritätsklinikum Bonn
    • Mr.  PD. Dr.  Robert  Pflugmacher 
    • Sigmund Freud Str 25
    • 53113  Bonn
    • 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
    • Orthopädie und Unfallchirurgie Univeritätsklinikum Bonn
    • Mr.  PD. Dr.  Robert  Pflugmacher 
    • Sigmund Freud Str 27
    • 53113  Bonn
    • 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
    • Orthopädie und Unfallchirugie Unversitätsklinikum Bonn
    • Mr.  PD Dr.  Robert  Pflugmacher 
    • Sigmund Freud Str. 25
    • 53127  Bonn
    • 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 continuing
  •   [---]*
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.