Trial document




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  DRKS00007996

Trial Description

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Title

Impact of morbid obesity (BMI >40 kg/m2) on complication rate following minimally invasive transforaminal lumbar interbody fusion

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

As part of a stabilization of the lumbar spine, screws are introduced through a bony bridge (pedicle) into the vertebral body; furthermore, a spacer (cage) is introduced into the intervertebral disc space to ensure sufficient stability in spinal segments with instability or degenerative disease. The minimally invasive technique called transforaminal lumbar interbody fusion (MIS TLIF) offers advantages compared to the open technique such as smaller incisions, less muscle trauma, less frequent wound complications, less blood loss during surgery, earlier mobilization and earlier discharge from hospital. For this surgical technique, the evidence regarding the perioperative and postoperative complication rate in patients with morbid obesity (body mass index (BMI) >40 kg/m2) is scarce. Existing studies attested no significantly increased risk in patients with a BMI >30 kg/m2. The portion of patients with a BMI >40 kg/m2, however, was low in these studies. Data regarding the perioperative and postoperative complications after MIS TLIF in patients exclusively with a BMI >40 kg/m2 is not available.
The aim of this research project is the retrospective investigation of perioperative and postoperative complications in patients with a BMI >40 kg/m2 after minimally invasive lumbar interbody fusion (MIS TLIF) and their comparison with patients with a normal weight (BMI of 20-25 kg/m2).

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Brief Summary in Scientific Language

As part of a stabilization of the lumbar spine, transpedicular screws are introduced into the vertebral body, and a cage is introduced into the intervertebral disc space to ensure sufficient stability in spinal segments with instability or degenerative disease. The minimally invasive technique called transforaminal lumbar interbody fusion (MIS TLIF) offers advantages compared to the open technique such as smaller incisions, less muscle trauma, less frequent wound complications, less blood loss during surgery, earlier mobilization and earlier discharge from hospital. For this surgical technique, the evidence regarding the perioperative and postoperative complication rate in patients with morbid obesity (body mass index (BMI) >40 kg/m2) is scarce. Existing studies attested no significantly increased risk in patients with a BMI >30 kg/m2. The portion of patients with a BMI >40 kg/m2, however, was low in these studies. Data regarding the perioperative and postoperative complications after MIS TLIF in patients exclusively with a BMI >40 kg/m2 is not available.
The aim of this research project is the retrospective investigation of perioperative and postoperative complications in patients with a BMI >40 kg/m2 after minimally invasive lumbar interbody fusion (MIS TLIF) and their comparison with patients with a normal weight (BMI of 20-25 kg/m2).

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Organizational Data

  •   DRKS00007996
  •   2015/04/08
  •   [---]*
  •   yes
  •   Approved
  •   124/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   M53.26 -  [generalization M53.2: Spinal instabilities]
  •   M43.16 -  [generalization M43.1: Spondylolisthesis]
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Interventions/Observational Groups

  •   Assessment of perioperative and postoperative complications in patients with morbid obesity (BMI >40 kg/m2) who underwent MIS TLIF between March 2009 and February 2014 due to lumbar instability or degeneration.
  •   Assessment of perioperative and postoperative complications in matched normal weight patients (BMI 20-25 kg/m2) who underwent MIS TLIF between March 2009 and February 2014 due to lumbar instability or degeneration.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Occurrence of major complications within 30 days of MIS TLIF: death, myocardial infarction, stroke, pulmonary embolism, severe pneumonia / mechanical ventilation, reoperation, new motor deficit grade ≤ 3/5.

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Secondary Outcome

Occurrence of minor complications within 30 days of MIS TLIF: new motor deficit grade > 3/5, slight pneumonia / transient dependency on oxygen, postoperative confusion, urinary tract infection, anemia requiring transfusion, deep vein thrombosis, intraoperative durotomy, hepatic impairment, depressive episode, sacroiliac joint syndrome. Duration of surgery, length of hospital stay, need for analgesics (WHO level).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/04/06
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Patients with morbid obesity (BMI >40 kg/m2) and matched normal weight patients (BMI 20-25 kg/m2) who underwent MIS TLIF between March 2009 and February 2014 due to lumbar instability or degeneration.

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Exclusion Criteria

Patients without morbid obesity or not normal-weight patients in the matched group. MIS TLIF due to infection or trauma.

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Addresses

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

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    • Universitätsklinikum Freiburg
    • 79095  Freiburg
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/07/10
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Trial Publications, Results and other Documents

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