Trial document




drksid header

  DRKS00006726

Trial Description

start of 1:1-Block title

Title

Cement augmentation of cannulated and fenestrated screws in posterior fusion procedures of the thoracic and lumbar spine

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

Stabilization procedures with screws and rods are an accepted therapy of various diseases of the spine (due to degeneration, cancer, or bone fractures due to accidents) to ensure sufficient stability oft he spine. In particular, elderly patients may have a decreased bone quality (osteoporosis). Therefore, the primary and long-lasting hold of the screws in the bone can be impaired. A loosening of the implants and thus instability of the spine with corresponding symptoms such as pain or neurological deficits (such as paralysis, numbness) may then be the result. To avoid this, bone cement has been placed around the screw in the vertebral body by various techniques. Biomechanical studies have confirmed a firmer hold of the screws by cementation. However, cementation also carries the risk of unintended cement leakage causing pain, nerve compression, neurological deficits, and pulmonary embolism. A new development are fenestrated screws, which are hollow and have small openings on the front third of the thread. After insertion of the screw in the vertebral body, viscous bone cement is injected through the screw and the openings into the vertebral body. With this technique, a more ergonomic and controlled injection of cement is achieved. Biomechanical studies on cadavers and first clinical reports with small patient numbers on this technique are available.
The aims of this research project are to describe the minimally invasive technique of cementing fenestrated screws with a new injection cannula, to retrospectively detect complications (cement leakage, screw loosening), and to report our clinical experience of the cementation of fenestrated screws in a relatively large patient population.

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

Brief Summary in Scientific Language

Stabilization procedures with screws and rods are an accepted therapy of various diseases of the spine (due to degeneration, cancer, or bone fractures due to accidents) to ensure sufficient stability oft he spine. In particular, elderly patients may have osteoporosis. Therefore, the primary and long-lasting hold of the screws in the bone can be impaired. A loosening of the implants and thus instability of the spine with corresponding symptoms such as pain or neurological deficits (such as paralysis, numbness) may then be the result. To avoid this, bone cement has been placed around the screw in the vertebral body by various techniques. Biomechanical studies have confirmed a firmer hold of the screws by cementation. However, cementation also carries the risk of unintended cement extravasation causing pain, nerve compression, neurological deficits, and pulmonary embolism. A new development are fenestrated screws, which are hollow and have small openings on the front third of the thread. After insertion of the screw in the vertebral body, viscous bone cement is injected through the screw and the openings into the vertebral body. With this technique, a more ergonomic and controlled injection of cement is achieved. Biomechanical studies on cadavers and first clinical reports with small patient numbers on this technique are available.
The aims of this research project are to describe the minimally invasive technique of cement-augmented fenestrated screws with a new injection cannula, to retrospectively detect complications (cement extravasation, screw loosening), and to report our clinical experience of cement-augmented fenestrated screws in a relatively large patient population.

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

Organizational Data

  •   DRKS00006726
  •   2014/09/05
  •   [---]*
  •   yes
  •   Approved
  •   417/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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

  •   M53.24 -  [generalization M53.2: Spinal instabilities]
  •   M53.26 -  [generalization M53.2: Spinal instabilities]
  •   M81.98 -  [generalization M81.9: Osteoporosis, unspecified]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Posterior thoracic and lumbar stabilization (Th1 - S1) using a screw-rod-spondylodesis with cement-augmented fenestrated screws
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

Verification of cement extravasation in the postoperative computed tomography.

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

Secondary Outcome

Verification of screw loosening in the postoperative computed tomography.
Proof of postoperative symptoms, which are attributable to cement extravasation/screw loosening.

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
  •   2014/09/09
  •   35
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients with posterior cement-augmented screw-rod-spondylodesis of the thoracic and lumbar spine from January 2012 to December 2012.

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

Exclusion Criteria

Patients of age < 18 years.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • 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
    • Neurochirurgische Universitätsklinik Freiburg
    • Mr.  Dr. med.  Jan-Helge  Klingler 
    • Breisacher Str. 64
    • 79106  Freiburg
    • 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
    • Neurochirurgische Universitätsklinik Freiburg
    • Mr.  Dr. med.  Jan-Helge  Klingler 
    • Breisacher Str. 64
    • 79106  Freiburg
    • 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
    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • 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
  •   2014/09/22
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.