Low Back Pain Clinical Trial
Official title:
RCT Comparing i-FACTOR and Allograft in Spinal Fusion Surgery
The average life expectancy in Denmark is increasing resulting in an increasing part of the
population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes
constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back,
especially when standing and walking, known as neurogenic claudicatio(Goh KJ FAU - Khalifa
et al.). LSS occurs in a combination of degenerative changes in the lower back, including
hypertrophy of the ligamentum flavum, arthrosis of the facet joints and bulging of the disc.
Current treatment of LSS is varied ranging from non-operativ conservative treatment to
operation.
Operative intervention shows very good results according to physical ability and
pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.),
but the most optimal treatment is still debated. Nevertheless, a decompression and, if
needed, a spinal fusion is recommented.(Ausman).
The investigators want to se whether i-FACTOR improves clinical outcomes compared to using
allograft in spinal fusion in the elderly, and thereby find an improved methods operating
this diffycult patient population.
The hypothesis is, that there is no difference in clinical outcomes whether you use i-FACTOR
or allograft i non-instrumentated spinal fusion surgery in patients with spinal stenosis due
to degenerative listhesis.
Se above ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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