An observational study in Spinal Stenosis and Spinal Cord Compression, sponsored by St. Olavs Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-08.
Sponsored by St. Olavs Hospital · Observational
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).
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's enrollment of 721 is above the median of 120 across 154 observational studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →St. Olavs Hospital is the lead sponsor of 171 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients who had operation in ≤2 lumbar levels with either open decompressive laminectomy, bilateral microdecompression or unilateral microdecompression for bilateral decompression in Norway in the time period between October 2006 and December 2011
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
surgical microdecompression using a bilateral or unilateral approach depending on the surgeon's preference and the individual patient's anatomy and symptoms.
Procedure: microdecompression
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
a minimal invasive surgical technique
The traditional open surgical technique: decompression with removal of the spinous process, lamina and often the medial facets
change in Oswestry Disability Index
collected through the Norwegian Registry for Spine Surgery (NORspine)
Time frame: between baseline and 12-months follow-up
changes in health-related quality of life
measured by Euro-Qol-5D, collected through the Norwegian Registry for Spine Surgery (NORspine)
Time frame: between baseline and 12-months follow-up
patient reported post-operative complications
wound infection, urinary tract infection, pneumonia, pulmonary embolism, and deep venous thrombosis
Time frame: 3 months
surgeon reported complication
intraoperative hemorrhage requiring blood replacement, unintentional durotomy, cardiovascular complications, respiratory complications, anaphylactic reactions, and wrong level surgery
Time frame: reported at discharge (expected average hospital stay of 3 days)
Length of hospital stay
Length of hospital stay before discharge
Time frame: reported at discharge (expected average hospital stay of 3 days)
Length of surgery
Length of surgery
Time frame: reported at discharge (expected average hospital stay of 3 days)
The record gives a start of Jan 2014, a primary completion of Jan 2015 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.