Trial document





This trial has been registered retrospectively.
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  DRKS00003695

Trial Description

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Title

Validation of bipolar pedicle stimulation in transpedicular lumbar fusion

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

During spinal fusion operations the screw has to pass through a bony bridge (pedicle) into the vertebral body. With correct placement, the screw is surrounded by bone while passing through this pedicle. If the screw deviates and leaves the pedicle, the adjacent located nerve can be compressed/damaged. In this case, the screw perforates the bone of the pedicle BEFORE it may damage the nerve. For many years, electric "pedicle stimulation" for correct pedicle screw placement is being employed, especially in the United States. Here, the placed screw is set under electric current or the manufactured channel through the pedicle is being explored with an electrified probe before placement of the screw. Usually, a higher stimulation intensity is needed to overcome the bony barrier around the screw or the channel in order to stimulate the adjacent nerve. If low intensity is needed only, one can assume, that the pedicle is perforated, because then the current can flow with lower resistance to the nerve. In such a case the screw can be directly revised or a new correct channel can be set. This stimulation technique so far is being used only with a specific (monopolar) stimulation setup, where the current flows from the tip of the probe through the tissue to another contact at the surface of the skin close to the wound. There is another stimulation setup available, which is being equally used for decades in neurosurgery, but has not been used for this specific task, the bipolar technique. Here, the probe has both contacts at the tip, the current flows from one directly to the adjacent one. Given the characteristic features of the two stimulation techniques, the use of bipolar stimulation should yield better results.
In this study the two techniques will be directly employed in every patient in two positions. The results will be compared with the radiologic pictures of the screw positions during and after the operation in order to compare the techniques and their diagnostic value. Adult patients with planned spondylodesis between L2 and S1 are included

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Brief Summary in Scientific Language

Electric stimulation for correct pedicle screw placement is a widely employed technique in lumbar transpedicular instrumentation, especially in the United States. However, it is being used only with a monopolar stimulation setup. Given the characteristic neurophysiologic features of the different available techniques, the use of bipolar stimulation should result in better selectivity, sensitivity and specificity, because it should need higher stimulation intensities to overcome an intact pedicle, trigger the nerve at risk and elicit a compound muscle action potential (CMAP) in the EMG, whereas the needed stimulation intensity in case of a pedicle breach should not differ very much compared to monopolar stimulation.
In this study the two techniques will be directly employed in every patient in two positions. One, at the level of the neuroforamen and second, inside the vertebral body, whereas the assumption is, that the position of the stimulation probe is of importance and only the placement at the level of the neuroforamen will give adequate results for both techniques.
The results will be compared to K-wire and screw position in fluoroscopy, intraoperative 3D-scan and postoperative CT-control. Sensitivity and specificity of the two techniques as well as a threshold analysis for the prediction of a pedicle perforation will be calculated. Adult patients with planned spondylodesis between L2 and S1 are included

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Organizational Data

  •   DRKS00003695
  •   2012/04/18
  •   [---]*
  •   yes
  •   Approved
  •   314/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   lumbar instability
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Interventions/Observational Groups

  •   monopolar vs. bipolar stimulation at the level of the neuroforamen; monopolar vs. bipolar stimulation inside the vertebral body
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Sensitivity and specificity of bipolar stimulation vs. monopolar stimulation with regard to intraoperative pedicle perforation

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Secondary Outcome

Selectivity of bipolar vs. monopolar nerve stimulation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/01/09
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

adult competent patients with planned lumbar transpedicular spondylodesis between L2 and S1;
in revision cases, the newly instrumented levels can be included, if between L2 and S1;
in longer instrumenation above L2 and/or below S1, the levels between L2 and S1 can be included

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Exclusion Criteria

implanted cardiac pacemaker or deep brain stimulation;
in revision cases, the previous instrumented levels can not be included;
in longer instrumentation, the levels above L2 an/or below S1 are excluded

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Neurochirurgische Universitätsklinik
    • Mr.  Dr. med.  Ronen  Sircar 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Neurochirurgische Universitätsklinik
    • Mr.  Dr. med.  Ronen  Sircar 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.