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Clinical Trial Summary

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.


Clinical Trial Description

Se above ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02895555
Study type Interventional
Source Sygehus Lillebaelt
Contact
Status Completed
Phase Phase 4
Start date March 2012
Completion date January 2016

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