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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decompression without fusion | Experimental | Surgery of the stenotic spinal segments with decompression of the neural elements without concommitant fusion. |
|
| Decompression with fusion | Experimental | Surgery of the stenotic spinal segments with decompression of the neural elements with concommitant fusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decompression without fusion | Procedure | Decompressive surgery of both central and lateral component of the stenosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index (ODI) | A difference in ODI of 12 at follow up between the two interventions is considered as significant. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Back pain | The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant. | 2 years |
| Leg pain | The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27074066 | Derived | 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. |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| ID | Term |
|---|---|
| D003664 | Decompression |
| D050939 | Gene Fusion |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011312 | Pressure |
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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| 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. |
|
| 2 years |
| EuroQol (EQ-5D) | Measurement of quality of life | 2 years |
| Swiss Spinal Stenosis Questionnaire | A disease-specific self-report outcome instrument commonly used in trials to measure treatment outcomes in patients with lumbar spinal stenosis. The Swiss Spinal Stenosis Questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment. It was designed to complement existing generic measures of lumbar spine disability and health status in the evaluation of patients with lumbar spinal stenosis. | 2 years |
| D055009 |
| Spondylosis |
| D011995 |
| Recombination, Genetic |
| D055614 | Genetic Phenomena |