Spinal Stenosis Clinical Trial
Official title:
Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis - An Observational Study
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).
Status | Completed |
Enrollment | 721 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Norway | St.Olavs Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
St. Olavs Hospital | Norwegian University of Science and Technology |
Norway,
Nerland US, Jakola AS, Solheim O, Weber C, Rao V, Lønne G, Solberg TK, Salvesen Ø, Carlsen SM, Nygaard ØP, Gulati S. Minimally invasive decompression versus open laminectomy for central stenosis of the lumbar spine: pragmatic comparative effectiveness stu — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in Oswestry Disability Index | collected through the Norwegian Registry for Spine Surgery (NORspine) | between baseline and 12-months follow-up | No |
Secondary | 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 | No |
Secondary | patient reported post-operative complications | wound infection, urinary tract infection, pneumonia, pulmonary embolism, and deep venous thrombosis | 3 months | No |
Secondary | 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) | No |
Secondary | Length of hospital stay | Length of hospital stay before discharge | reported at discharge (expected average hospital stay of 3 days) | No |
Secondary | Length of surgery | Length of surgery | reported at discharge (expected average hospital stay of 3 days) | No |
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