Clinical Research Directory

The NORDSTEN Study - Degenerative Spondylolisthesis

Sponsor: Haukeland University Hospital

Summary

Lumbar Degenerative Spondylolisthesis (LDS) is a slippage of one vertebra over another caused by degeneration of facet joints, ligaments and intervertebral discs. Most patients suffer from symptoms related to spinal stenosis, such as radiating pain to the lower extremities, and typically increased pain in the lower limbs when walking upright and decreased when bending forward. There is a moderate grade of evidence for whether patients will achieve better outcome after surgery when decompression is followed by fusion. In theory, fusion following decompression should give more stability to the operated level, thus less pain and less progression of the olisthesis. On the other hand, fusion procedures, in general, are associated with more severe complications and postoperative mortality than decompression alone. In summary, there is still insufficient evidence for performing fusion in addition to decompression for patients with LDS. The investigators are planning a trial where the main aim is to detect whether the intervention-related difference in outcome between decompression alone (DA) and decompression followed by fusion with instrumentation (DF) is large enough to justify the use of the fusion procedure. The proposed trial is a randomized, controlled, multicentre, non- inferiority trial with two parallel groups, with 15 participating Norwegian hospitals. The main analysis will be performed 2 years after surgery with long-term follow-up planned at 5 and 10 years postoperatively.

Official title: Degenerative Lumbar Spondylolisthesis: Is Only Decompression Good Enough? A Prospective Randomized Clinical Multi- Institutional Trial

Key Details

Conditions

Interventions

Locations (1)