Clinical trial NCT02006901: Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis
Official title: Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis - An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Stenosis
Spinal Cord Compression
Keywords: surgical procedures, operative
lumbar vertebrae
decompression, surgical
microdecompression
laminectomy
registries
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2013-12-10
Enrollment: 721
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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).


Eligibility criteria: 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.

Primary outcomes:
measure: change in Oswestry Disability Index
timeFrame: between baseline and 12-months follow-up
Secondary outcomes:
measure: changes in health-related quality of life
timeFrame: between baseline and 12-months follow-up
measure: patient reported post-operative complications
timeFrame: 3 months
measure: surgeon reported complication
timeFrame: reported at discharge (expected average hospital stay of 3 days)
measure: Length of hospital stay
timeFrame: reported at discharge (expected average hospital stay of 3 days)
measure: Length of surgery
timeFrame: reported at discharge (expected average hospital stay of 3 days)
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St.Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Sasha Gulati, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.