Swedish Spinal Stenosis Study

NCT01994512 | Completed

• 1 other identifier: SS 01
• Study Type: interventional
• Target: 245
• Locations: 0 countries
• Sites: N/A

Brief Summary

A national randomized multicentre trial (RCT) where decompression is compared with decompression with simultaneous fusion in 245 patients with spinal stenosis on one or two adjacent lumbar levels with or without degenerative olisthesis. The material is stratified for the existence of degenerative olisthesis \>3mm. Monitoring is performed with clinical results from patient surveys after 2 and five years, and with radiological follow-up (MRI, CT and plain X-ray) and an objective function test (6 min walking test) after 2 years. The null hypothesis is that there is no difference in results between the two interventions.

Conditions

Lumbar Spinal Stenosis

Keywords

Spinal stenosis; Decompression; Fusion; Olisthesis

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI)

  A difference in ODI of 12 at follow up between the two interventions is considered as significant.

  2 years

Secondary Outcomes (4)

• Back pain

  2 years

• Leg pain

  2 years

• EuroQol (EQ-5D)

  2 years

• Swiss Spinal Stenosis Questionnaire

  2 years

Study Arms (2)

Decompression without fusion

EXPERIMENTAL

Surgery of the stenotic spinal segments with decompression of the neural elements without concommitant fusion.

Procedure: Decompression without fusion

Decompression with fusion

EXPERIMENTAL

Surgery of the stenotic spinal segments with decompression of the neural elements with concommitant fusion.

Procedure: Decompression with fusion

Interventions

Decompression without fusion PROCEDURE

Decompressive surgery of both central and lateral component of the stenosis.

Decompression without fusion

Decompression with fusion PROCEDURE

Decompressive surgery of both central and lateral component of the stenosis AND concomitant instrumented or uninstrumented posterior fusion of decompressed segments.

Decompression with fusion

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pseudoclaudication in one or both legs and backpain (VAS\>30)
• MRI with 1-2 adjacent stenotic segments (area \<0.75 mm2)between L2 and sacrum
• Duration of symptoms \>6 months
• Informed consent

You may not qualify if:

• Spondylolysis
• Degenerative lumbar scoliosis (Cobb angle \>20 deg)
• History of lumbar spinal surgery for spinal stenosis or instability
• Stenosis not caused by degenerative changes
• Stenosis caused by herniated disc
• Other specific spinal conditions, Mb Bechterew, malignancy, neurologic disorders
• History of vertebral compression fractures in affected segments
• Psychological disorders where the surgeon considers participation inappropriate(dementia, drug abuse)

Sponsors & Collaborators

• Uppsala University: lead

Related Publications (1)

• Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, Ohagen P, Michaelsson K, Sanden B. A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. N Engl J Med. 2016 Apr 14;374(15):1413-23. doi: 10.1056/NEJMoa1513721.

  PMID: 27074066 DERIVED

MeSH Terms

Conditions

Spinal Stenosis; Spondylolisthesis

Interventions

Decompression; Gene Fusion

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Intervention Hierarchy (Ancestors)

Therapeutics; Pressure; Mechanical Phenomena; Physical Phenomena; Recombination, Genetic; Genetic Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 25, 2013
• Study Start: October 1, 2006
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2014
• Last Updated: December 17, 2015

Record last verified: 2015-12