Spinal StenosisNCT02006901
Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis
An observational study of Spinal Stenosis and Spinal Cord Compression, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Stenosis, Spinal Cord Compression
- What is being tested?
- microdecompression and laminectomy
- Type of treatment
- Surgery or procedure
- How many people
- 721 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2014to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Spinal Stenosis, Spinal Cord Compression
- Being tested
- microdecompression, laminectomy
- Keywords
- surgical procedures, operative, lumbar vertebrae, decompression, surgical, microdecompression, laminectomy, registries
- Medical subject headings
- Spinal Stenosis, Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microdecompressionProcedure or surgery
a minimal invasive surgical technique
laminectomyProcedure or surgery
The traditional open surgical technique: decompression with removal of the spinous process, lamina and often the medial facets
| Study group | Role | What they receive |
|---|---|---|
| microdecompression | surgical microdecompression using a bilateral or unilateral approach depending on the surgeon's preference and the individual patient's anatomy and symptoms. Receives: Procedure: microdecompression | |
| laminectomy | the spinous process and the laminae of the involved level(s) as well as the medial aspects of the facet joints are resected Receives: Procedure: laminectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Oswestry Disability Index
collected through the Norwegian Registry for Spine Surgery (NORspine)
Measured: between baseline and 12-months follow-up
Secondary outcomes (5)
changes in health-related quality of life
measured by Euro-Qol-5D, collected through the Norwegian Registry for Spine Surgery (NORspine)
Measured: between baseline and 12-months follow-up
patient reported post-operative complications
wound infection, urinary tract infection, pneumonia, pulmonary embolism, and deep venous thrombosis
Measured: 3 months
surgeon reported complication
intraoperative hemorrhage requiring blood replacement, unintentional durotomy, cardiovascular complications, respiratory complications, anaphylactic reactions, and wrong level surgery
Measured: reported at discharge (expected average hospital stay of 3 days)
Length of hospital stay
Length of hospital stay before discharge
Measured: reported at discharge (expected average hospital stay of 3 days)
Length of surgery
Length of surgery
Measured: reported at discharge (expected average hospital stay of 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 721 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Sasha Gulati, MD, PhD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006901
- Sponsor's protocol ID
- 2013/643
- Status last verified
- Apr 2015
- First submitted
- 2 Dec 2013
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25833966Nerland 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.
PubMed 24650809
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis - An Observational Study
- ClinicalTrials.gov ID
- NCT02006901
- Acronym / sponsor ID
- 2013/643
- Conditions
- Spinal Stenosis, Spinal Cord Compression
- Keywords
- surgical procedures, operative, lumbar vertebrae, decompression, surgical, microdecompression, laminectomy, registries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 721 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microdecompression | – | Procedure: microdecompressionsurgical microdecompression using a bilateral or unilateral approach depending on the surgeon's preference and the individual patient's anatomy and symptoms. |
| laminectomy | – | Procedure: laminectomythe spinous process and the laminae of the involved level(s) as well as the medial aspects of the facet joints are resected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microdecompressiona minimal invasive surgical technique | Procedure or surgery | microdecompression |
| laminectomyThe traditional open surgical technique: decompression with removal of the spinous process, lamina and often the medial facets | Procedure or surgery | laminectomy |
Primary outcome
change in Oswestry Disability Index
Time frame: between baseline and 12-months follow-up
collected through the Norwegian Registry for Spine Surgery (NORspine)
5 secondary outcomes
changes in health-related quality of life
Time frame: between baseline and 12-months follow-up
patient reported post-operative complications
Time frame: 3 months
surgeon reported complication
Time frame: reported at discharge (expected average hospital stay of 3 days)
Length of hospital stay
Time frame: reported at discharge (expected average hospital stay of 3 days)
Length of surgery
Time frame: reported at discharge (expected average hospital stay of 3 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Results publication: PubMed 25833966Nerland 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.
- Derived from this study: PubMed 24650809Nerland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sasha Gulati, MD, PhD principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Stenosis and Spinal Cord Compression, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Oswestry Disability Index (time frame: between baseline and 12-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02006901, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015; AzTrials last refreshed its copy on 30 Oct 2026.