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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| microdecompression | surgical microdecompression using a bilateral or unilateral approach depending on the surgeon's preference and the individual patient's anatomy and symptoms. |
| |
| laminectomy | the spinous process and the laminae of the involved level(s) as well as the medial aspects of the facet joints are resected |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microdecompression | Procedure | a minimal invasive surgical technique |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Sasha Gulati, MD, PhD | St. Olavs Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Olavs Hospital | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25833966 | Result | Nerland US, Jakola AS, Solheim O, Weber C, Rao V, Lonne G, Solberg TK, Salvesen O, Carlsen SM, Nygaard OP, Gulati S. Minimally invasive decompression versus open laminectomy for central stenosis of the lumbar spine: pragmatic comparative effectiveness study. BMJ. 2015 Apr 1;350:h1603. doi: 10.1136/bmj.h1603. | |
| 24650809 | Derived |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D013117 | Spinal Cord Compression |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013118 | Spinal Cord Diseases |
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| ID | Term |
|---|---|
| D007796 | Laminectomy |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
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| laminectomy |
| Procedure |
The traditional open surgical technique: decompression with removal of the spinous process, lamina and often the medial facets |
|
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) |
| Nerland US, Jakola AS, Solheim O, Weber C, Rao V, Lonne G, Solberg TK, Salvesen O, Carlsen SM, Nygaard OP, Gulati S. Comparative effectiveness of microdecompression and laminectomy for central lumbar spinal stenosis: study protocol for an observational study. BMJ Open. 2014 Mar 20;4(3):e004651. doi: 10.1136/bmjopen-2013-004651. |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013119 | Spinal Cord Injuries |
| D014947 | Wounds and Injuries |
| D019635 | Neurosurgical Procedures |