The Lumbar Adjacent Segment Stenosis Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOslo University Hospital

About this trial

The goal of this clinical trial is to learn if there are differences in the effectiveness of decompression surgery alone versus decompression combined with extended fusion in patients with a previous lumbar spinal fusion who now present with symptoms of lumbar adjacent segment stenosis (LASS). The main questions it aims to answer are:

* Does decompression alone differ from decompression combined with extended fusion with regard to clinical outcomes two years after surgery? * Are there any clinical or radiological characteristics that can predict better or worse outcomes two years after surgery? * Are there any differences between the treatment groups in terms of health economics?

Researchers will compare decompression surgery alone versus decompression combined with extended fusion to see if there are any differences in treatment effect.

Participants will:

* Be randomized to one of the two surgical procedures * Visit the clinic four times postoperatively (at three months, 1, 2 and 5 years) for checkups and tests * Respond to questionnaires before surgery, and three months, 1, 2 and 5 years postoperatively

Eligibility criteria

Qualifiers

Clinical symptoms of spinal stenosis, defined as neurogenic claudication or radiating pain into the lower limbs with duration >6 months

MRI-confirmed adjacent segment stenosis, proximal to a previously fused lumbar segment (fusion of maximum two levels between L1 and S1, any type of previous lumbar fixation procedure).

CT-verified solid fusion

Minimum time since previous fusion: one year

Disqualifiers

Previous surgery at the actual adjacent stenotic level.

More than two fused lumbar levels.

Non-union (pseudoarthrosis) at the previously surgically fused level, radiologically verified.

Foraminal stenosis grade 3 at the adjacent level.

Trial design

Treatments tested in this trial

  • Decompression alone
  • Decompression with extended fusion

Treatment groups

192 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Oslo University Hospital

Lead sponsor

Sykehuset Innlandet HF

Collaborator

University Hospital of North Norway

Collaborator