Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-invasive Decompression to X-stop

Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-Invasive Decompression to X-Stop (LSSS)

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00546949

Acronym

LSSS

Enrollment

Registered

2007-10-19

Start date

2007-03-31

Completion date

2013-12-31

Last updated

2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spinal Stenosis, Radiculopathy

Keywords

Decompression, Surgical, x-stop, lumbar decompression, spinal stenosis, radiculopathy

Brief summary

The purpose of this study is to compare two surgery methods on lumbar spinal stenosis: minimal invasive decompression and X-stop. It is a prospective randomized multicenter study including patients with lumbar spinal stenosis on one or two levels, and neurogenic intermittent claudication. Effect assessment will include measures of pain and self-evaluated health condition, a full economical evaluation, and areal measurements (MR imaging and roentgen analyses)

Interventions

PROCEDUREMinimal invasive decompression

foraminotomy, laminotomy, microscopic decompression

PROCEDUREInterspinous Process Decompression (IPD)

Interspinous device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Inclusion criteria

* neurogenic intermittent claudication due to lumbar spinal stenosis * diagnosed on MRI in maximum two levels * walking distance on 250 metres * symptom relief on flexion of the lumbar spine * duration of the symptoms more than 6 months * non-operative treatment is tried or considered as not indicated

Exclusion criteria

* vascular claudicatio intermittens * spinal stenosis on more than 2 levels * cauda equina syndrome * severe paresis * clinical monoradiculopathy * grave scoliosis * previous lumbar surgery * degenerative spondylolisthesis more than 25% * spondylolysis with listhesis * osteoporotic fracture in lumbal column * clinical and radiological (both) arthritis in the hip joint * ASA \>3 * verified polyneuropathy on neurophysiological test

Design outcomes

Primary

Measure	Time frame	Description
Claudication	2 years	Zürich Claudication Questionnaire

Secondary

Measure	Time frame	Description
self-evaluated health condition	2 years	SF36, Oswestry Disability Index (ODI), EQ5-D and VAS scale

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026