Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis
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|ClinicalTrials.gov Identifier: NCT02006901|
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : April 8, 2015
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).
|Condition or disease||Intervention/treatment|
|Spinal Stenosis Spinal Cord Compression||Procedure: microdecompression Procedure: laminectomy|
|Study Type :||Observational|
|Actual Enrollment :||721 participants|
|Official Title:||Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis - An Observational Study|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
surgical microdecompression using a bilateral or unilateral approach depending on the surgeon's preference and the individual patient's anatomy and symptoms.
a minimal invasive surgical technique
the spinous process and the laminae of the involved level(s) as well as the medial aspects of the facet joints are resected
The traditional open surgical technique: decompression with removal of the spinous process, lamina and often the medial facets
- change in Oswestry Disability Index [ Time Frame: between baseline and 12-months follow-up ]collected through the Norwegian Registry for Spine Surgery (NORspine)
- changes in health-related quality of life [ Time Frame: 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 [ Time Frame: 3 months ]wound infection, urinary tract infection, pneumonia, pulmonary embolism, and deep venous thrombosis
- surgeon reported complication [ Time Frame: 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 [ Time Frame: reported at discharge (expected average hospital stay of 3 days) ]Length of hospital stay before discharge
- Length of surgery [ Time Frame: reported at discharge (expected average hospital stay of 3 days) ]Length of surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02006901
|Principal Investigator:||Sasha Gulati, MD, PhD||St. Olavs Hospital|