Swedish Spinal Stenosis Study (SSSS)

Uppsala University

Status: Completed

Conditions: Lumbar Spinal Stenosis

Treatments: Procedure: Decompression with fusion; Procedure: Decompression without fusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01994512

SS 01

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 2 patient groups

Decompression without fusion

Experimental group

Description:

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

Treatment:

Procedure: Decompression without fusion

Decompression with fusion

Experimental group

Description:

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

Treatment:

Procedure: Decompression with fusion