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

Lumbar Spinal Stenosis Clinical Trial

— LSSS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00546949
• Other study ID #: NSSL-16279
• Status: Terminated
• Phase: N/A
• First received: October 18, 2007
• Last updated: February 24, 2016
• Start date: March 2007
• Est. completion date: December 2013

Study information

• Verified date: February 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: December 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Radiculopathy
• Spinal Stenosis

Intervention

Procedure:
• Minimal invasive decompression
foraminotomy, laminotomy, microscopic decompression
• Interspinous Process Decompression (IPD)
Interspinous device

Locations

Country	Name	City	State
Norway	Nastional Senter for Spinal Disorders	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Lønne G, Johnsen LG, Aas E, Lydersen S, Andresen H, Rønning R, Nygaard ØP. Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial. Spine (Phila Pa 1976). 2015 Apr 15;40(8):514- — View Citation

Lønne G, Johnsen LG, Rossvoll I, Andresen H, Storheim K, Zwart JA, Nygaard ØP. Minimally invasive decompression versus x-stop in lumbar spinal stenosis: a randomized controlled multicenter study. Spine (Phila Pa 1976). 2015 Jan 15;40(2):77-85. doi: 10.109 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Claudication	Zürich Claudication Questionnaire	2 years	No
Secondary	self-evaluated health condition	SF36, Oswestry Disability Index (ODI), EQ5-D and VAS scale	2 years	No