Spinal Cord Compression, Spinal Stenosis
Conditions
Keywords
surgical procedures, operative, lumbar vertebrae, decompression, surgical, microdecompression, laminectomy, registries
Brief summary
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).
Interventions
PROCEDUREmicrodecompression
a minimal invasive surgical technique
PROCEDURElaminectomy
The traditional open surgical technique: decompression with removal of the spinous process, lamina and often the medial facets
Sponsors
Norwegian University of Science and Technology
St. Olavs Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Oswestry Disability Index | between baseline and 12-months follow-up | collected through the Norwegian Registry for Spine Surgery (NORspine) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in health-related quality of life | between baseline and 12-months follow-up | measured by Euro-Qol-5D, collected through the Norwegian Registry for Spine Surgery (NORspine) |
| patient reported post-operative complications | 3 months | wound infection, urinary tract infection, pneumonia, pulmonary embolism, and deep venous thrombosis |
| surgeon reported complication | reported at discharge (expected average hospital stay of 3 days) | intraoperative hemorrhage requiring blood replacement, unintentional durotomy, cardiovascular complications, respiratory complications, anaphylactic reactions, and wrong level surgery |
| Length of hospital stay | reported at discharge (expected average hospital stay of 3 days) | Length of hospital stay before discharge |
| Length of surgery | reported at discharge (expected average hospital stay of 3 days) | Length of surgery |
Countries
Norway
Outcome results
None listed