Trial document
This trial has been registered retrospectively.
DRKS00000237
Trial Description
Title
Decompression versus Decompression and Fusion in patients with degenerative Spondylolisthesis. A prospective randomized, controlled clinical study
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.
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.
Organizational Data
- DRKS00000237
- 2009/11/30
- [---]*
- yes
- Approved
- 153/09, Ethik-Kommission bei der Ärztekammer des Saarlandes
Secondary IDs
- U1111-1112-5264
Health Condition or Problem studied
- M43.16 - [generalization M43.1: Spondylolisthesis]
Interventions/Observational Groups
-
Decompression:
undercutting decompression -
Decompression followed by Fusion:
undercutting decompression + PLIF
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
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
Countries of Recruitment
- Germany
Locations of Recruitment
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Recruitment
- Actual
- 2009/10/07
- 85
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 30 Years
- 80 Years
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
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
Addresses
-
start of 1:1-Block address primary-sponsor
- Klinik für Neurochirurgie Universitätsklinikum Homburg
- Mr. Dr. med. Abdullah Nabhan
- 66424 Homburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 06841-1624429
- 06841-1624413
- ncnabd at uniklinikum-saarland.de
- http://www.uniklinikum-saarland.de/de/einrichtungen/kliniken_institute/neurochirurgie
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Klinik für Neurochirurgie Universitätsklinikum des Saarlandes
- Mr. Dr. med. Abdullah Nabhan
- 66424 Homburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 06841-1624429
- [---]*
- ncnabd at uniklinikum-saarland.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Klinik für Neurochirurgie Universitätsklinikum des Saarlandes
- Mr. Dr. med. Abdullah Nabhan
- 66424 Homburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 06841-1624429
- [---]*
- ncnabd at uniklinikum-saarland.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Klinik für Neurochirurgie Universitätsklinikum des Saarlandes
- 66424 Homburg
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- http://www.uniklinikum-saarland.de/de/einrichtungen/kliniken_institute/neurochirurgie
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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