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

Norwegian University of Science and Technology

Status: Terminated

Conditions: Radiculopathy; Lumbar Spinal Stenosis

Treatments: Procedure: Interspinous Process Decompression (IPD); Procedure: Minimal invasive decompression

Study type: Interventional

Funder types: Other

Identifiers

NCT00546949

NSSL-16279

Details and patient eligibility

About

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)

Enrollment: 96 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

decompression

Active Comparator group

Description:

Minimal invasive decompression

Treatment:

Procedure: Minimal invasive decompression

x-stop

Experimental group

Description:

X-stop, an interspinous decompression device

Treatment:

Procedure: Interspinous Process Decompression (IPD)