Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis

Study Overview
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Brief Summary
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Introduction: This observational study is designed to test the equivalence between the clinical effectiveness of microdecompression and laminectomy in the surgical treatment of central lumbar spinal stenosis. Lumbar spinal stenosis is the most frequent indication for spinal surgery in the elderly, and as the oldest segment of the population continues to grow its prevalence is likely to increase. However, data on surgical outcomes are limited. Open or wide decompressive laminectomy, often combined with medial facetectomy and foraminotomy, was formerly the standard treatment. In recent years a growing tendency towards less invasive decompressive procedures has emerged. Many spine surgeons today perform microdecompression for central lumbar spinal stenosis. Prospectively registered treatment and outcome data are obtained from the Norwegian Registry for Spine Surgery (NORspine).

Official Title
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Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis - An Observational Study

Conditions
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Spinal Stenosis, Spinal Cord Compression

Intervention / Treatment
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* Procedure: microdecompression
* Procedure: laminectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of central lumbar spinal stenosis Operation in ≤2 lumbar levels with either open decompressive laminectomy, bilateral microdecompression or unilateral microdecompression for bilateral decompression in the time period between October 2006 and December 2011 Included in the NORspine registry Exclusion Criteria: History of lumbar fusion Previous surgery in the lumbar spine Discectomy as part of the decompression Associated pathological entities such as disc herniation, spondylolisthesis or scoliosis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| microdecompression<br>surgical microdecompression using a bilateral or unilateral approach depending on the surgeon's preference and the individual patient's anatomy and symptoms. | Procedure: microdecompression<br>* a minimal invasive surgical technique<br>|
| laminectomy<br>the spinous process and the laminae of the involved level(s) as well as the medial aspects of the facet joints are resected | Procedure: laminectomy<br>* The traditional open surgical technique: decompression with removal of the spinous process, lamina and often the medial facets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Oswestry Disability Index | collected through the Norwegian Registry for Spine Surgery (NORspine) | between baseline and 12-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in health-related quality of life | measured by Euro-Qol-5D, collected through the Norwegian Registry for Spine Surgery (NORspine) | between baseline and 12-months follow-up | 
| patient reported post-operative complications | wound infection, urinary tract infection, pneumonia, pulmonary embolism, and deep venous thrombosis | 3 months | 
| surgeon reported complication | intraoperative hemorrhage requiring blood replacement, unintentional durotomy, cardiovascular complications, respiratory complications, anaphylactic reactions, and wrong level surgery | reported at discharge (expected average hospital stay of 3 days) | 
| Length of hospital stay | Length of hospital stay before discharge | reported at discharge (expected average hospital stay of 3 days) | 
| Length of surgery | Length of surgery | reported at discharge (expected average hospital stay of 3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical procedures, operative, lumbar vertebrae, decompression, surgical, microdecompression, laminectomy, registries