Trial document




This trial has been registered retrospectively.
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  DRKS00000237

Trial Description

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Title

Decompression versus Decompression and Fusion in patients with degenerative Spondylolisthesis. A prospective randomized, controlled clinical study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Spondylolisthesis is a subluxation of one vertebral body on another due to long-standing intersegmental instability.
It leads to nerv root compression within confines of spinal canal.
The nerval compression may cause nerval damage and loss of function including neurological deficit of hip, legs, bladder and rectum. The spondylolisthesis may finally lead to vertebral disc herniation, spondylathrosis and low back pain.
Patients who present with sensory changes, muscle weakness, or cauda equina syndrome, are more likely to develop progressive functional decline without surgery.
The goal of surgical intervention is decompression of the neural structures to relieve pain and other neurologic symptoms.
The clinical standard is surgical decompression as well as surgical decompression followed by fusion. Both methods reveal relief of symptoms. To this day there is no evidence which procedure provides the better long term outcome.

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Brief Summary in Scientific Language

The objective of this study is to compare the clinical outcome of two standard surgical procedures for the treatment of degenrative spondylolisthesis. The surgical procedures are surgical decompression and surgical decompression followed by fusion.
The primary objective is the result of Oswestry Disability Index (ODI) at 12 months after surgery.
Secondary objetives are the evaluation of pain by Visual analogue scale (VAS) prior to and one week, 3, 6,9, months after surgery.
Additionally posoperative complications and the correllation between clinical outcome and radiological findings will be invastigated.

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Organizational Data

  •   DRKS00000237
  •   2009/11/30
  •   [---]*
  •   yes
  •   Approved
  •   153/09, Ethik-Kommission bei der Ärztekammer des Saarlandes
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Secondary IDs

  •   U1111-1112-5264 
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Health Condition or Problem studied

  •   M43.16 -  [generalization M43.1: Spondylolisthesis]
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Interventions/Observational Groups

  •   Decompression:
    undercutting decompression
  •   Decompression followed by Fusion:
    undercutting decompression + PLIF
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Change of the ODI score 12 months after surgery

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Secondary Outcome

Oswestry Disability Index one week, 3, 6, month after surgery;
VAS one week, 3, 6, 12 month after surgery
complications, such as instybility, wound healing disorder, ensuing degeneration
correlation of the clinical status and radiological results before and after surgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2009/10/07
  •   85
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   80   Years
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Additional Inclusion Criteria

Lumbal degenerative spondylolisthesis grade I° and II° according to Meyerding
ischialgia, claudication spinalis, lumbalgia
monosegmental degeneration
men and women in age of 30-80 years
no improvement under non surgical treatment within the last 3 month
patient's informend consent

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Exclusion Criteria

Lumbal degenerative spondylolisthesis grade III° and IV° according to Meyerding
previous surgical lumbar decompression with/without fusion
multisegmental degeneration
spine body tumor
spine body fracture, spine body trauma
thrombozythopenia/pathy
exogenous/endogenous coagulation disorder
marked osteoporosis
osteomalacia
relapse operation
adiposity
bone metabolic disease
chronic polyathritis
inflammatory autoimmune diseases
inflammatory diseases
systemic diseases (HIV, Hepatitis)
pregnancy, lactation period
demented patients, no informed consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Neurochirurgie Universitätsklinikum Homburg
    • Mr.  Dr. med.  Abdullah  Nabhan 
    • 66424  Homburg
    • Germany
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    • Klinik für Neurochirurgie Universitätsklinikum des Saarlandes
    • Mr.  Dr. med.  Abdullah  Nabhan 
    • 66424  Homburg
    • Germany
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    • Klinik für Neurochirurgie Universitätsklinikum des Saarlandes
    • Mr.  Dr. med.  Abdullah  Nabhan 
    • 66424  Homburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Neurochirurgie Universitätsklinikum des Saarlandes
    • 66424  Homburg
    • 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.