Spinal StenosisNCT02348645
Decompression vs. Fusion for Stable Degenerative Spondylolisthesis
A study testing Spinal fusion and Spinal decompression in people with Spinal Stenosis and Spondylolisthesis, run by University Health Network, Toronto at 8 sites in Canada.
Trial summary
The purpose of this study is to assess the feasibility of a full-scale multicenter randomized, controlled trial comparing the effectiveness of two surgical treatments for a condition associated with lumbar spinal stenosis called degenerative lumbar spondylolisthesis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Spinal Stenosis, Spondylolisthesis
- What is being tested?
- Spinal fusion and Spinal decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 8 sitesCanada
- Study dates
- Jul 2015to Aug 2023
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients deemed to be surgical candidates with focal (1-2 level) lumbar spinal stenosis (LSS) and associated stable degenerative spondylolisthesis with the following characteristics:
- a clinical history of back, buttock and leg pain with walking or standing that is improved when lying, sitting or bending forward
- a clinical history of leg symptoms that are greater than or equal to back symptoms with walking or standing, and
- greater than 6 months of symptoms with failed conservative care
- aged 50 or over
- sufficient fluency in English or French to provide informed consent and complete questionnaires with or without the need of an interpreter
Who cannot join
- Greater than 25% listhesis or spinal instability as demonstrated by motion (>5mm of translation) on flexion extension radiographs or non-loaded (MRI/CT or supine x-rays) to loaded imaging (standing radiograph)
- Presence of kyphosis (>0 degrees at the affected level or globally), degenerative scoliosis (>10 degree using the Cobb method) with rotatory or lateral listhesis on preoperative x-rays
- Clinical history of osteoporotic fracture or chronic oral steroid use
- Previous posterior lumbar spinal surgery (excluding prior microdiscectomy)
- Patients who have evidence of neurological disorders that affect physical function (e.g. peripheral neuropathy), neuromuscular disorders (e.g. multiple sclerosis, Parkinson's etc.) or systemic illness (e.g. inflammatory arthritis) that affects physical function
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2N9
Mackenzie Health Sciences Centre
Edmonton, Alberta, T6G 2B7
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University Health Network
Toronto, Ontario, M5T 2S8
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Decompression Alone vs. Decompression and Instrumented Fusion for the Management of Lumbar Spinal Stenosis Associated With Stable Degenerative Spondylolisthesis: A Pragmatic Randomized Clinical Pilot Trial
The purpose of this study is to assess the feasibility of a full-scale multicenter randomized, controlled trial comparing the effectiveness of two surgical treatments for a condition associated with lumbar spinal stenosis called degenerative lumbar spondylolisthesis. Both treatments are currently used, but individual surgeons use different selection criteria for each treatment and use the procedures at different rates. The two procedures are decompression with fusion (the most common surgical procedure for spondylolisthesis) and midline-sparing decompression alone (which is also a standard treatment, but is not as widely used for treating spondylolisthesis). The investigators plan to collect the evidence on the following:
- The feasibility of the trial protocol, and
- Preliminary data on the effectiveness of each treatment.
- Conditions
- Spinal Stenosis, Spondylolisthesis
- Being tested
- Spinal fusion, Spinal decompression
- Keywords
- Pilot projects, Feasibility studies, Intervention studies, Orthopedics, Orthopedic Procedures, Neurosurgical Procedures, Neurosurgery, Spine, Spinal Fusion, Spondylodesis, Spondylosyndesis, Laminectomy, Foraminotomy, Decompression, surgical, Low Back Pain, Quality of Life
- Medical subject headings
- Spinal Stenosis, Spondylolisthesis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal fusionProcedure or surgery
Spinal decompressionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Decompression with fusion | Active comparator | Spinal decompression surgery with instrumented spinal fusion Receives: Procedure: Spinal fusion; Procedure: Spinal decompression |
| Decompression alone | Active comparator | Midline-sparing spinal decompression alone Receives: Procedure: Spinal decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients recruited
Measured: 1 year
Number of eligible patients
Measured: 1 year
Reasons for refusal to consent
Measured: 1 year
Proportion of patients who adhere to randomized allocation
Measured: 2 years
Number of patients refusing to consent due to blinding
Measured: 1 year
Blinding status
Patient's assessment of which treatment they received
Measured: 1.5 months post-surgery
Oswestry Disability Index (ODI)
10-item patient-reported questionnaire measuring disability related to low back pain. Each item has six response options ranging from 0 to 5; the responses are summed and rescaled so 0 indicates no disability and 100 indicates extreme disability.
Measured: 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery
Proportion of patients who receive randomized allocation
Measured: 2 years
Number of patients refusing to consent due to randomization
Measured: 1 year
Number, type and severity of adverse events
Measured: End of hospital stay (average 6.5 days post-surgery)
Secondary outcomes (6)
Short-Form 12 scores: Physical Function, Bodily Pain, Physical Component Summary
12-item patient-reported questionnaire for general health status based on the SF-36 Health Survey (version 2). Measures eight health domains, each scored so 0 is the worst and 100 is the best possible score: general health (GH), physical function (PF), bodily pain (BP), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), mental health (MH), social functioning (SF), and energy/fatigue (VT). The domain scores can be aggregated into Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, also scaled so 0 is the worst and 100 is the best possible score. This study will focus primarily on the Physical Function domain, the Bodily Pain domain, and the Physical Component Summary score.
Measured: Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery
Euro-QoL health utility index
Patient-reported questionnaire for general health state which includes five items (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a visual analog scale for self-rated health state. Using an existing U.S. population-based value set, responses will be converted to the corresponding health utility index (1.0=perfect health and 0.0=death).
Measured: Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery
Patient Health Questionnaire-9 score
Patient-reported questionnaire that measures severity of depression symptoms. It is scored from 0 to 27, with the following interpretation: 0-4=no symptoms, 5-9=minimal symptoms; 10-14=mild/minor depression or dysthymia; 15-19=moderate major depression; 20-27=severe major depression.
Measured: Baseline
Costs incurred by patients
Measured: monthly from 1.5 to 12 months post-surgery; 24 months post-surgery
Hospital cost
Measured: End of hospital stay (average 6.5 days post-surgery)
Healthcare services used
Other Ontario Health Insurance Plan (OHIP)-billed services used
Measured: Referral to 1 year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2023
- Study completionAug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoga Raja Rampersaud, MD FRCSC, Principal investigator, University Health Network, TorontoAnthony Perruccio, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348645
- Sponsor's protocol ID
- 13-6927
- Status last verified
- May 2026
- First submitted
- 9 Sep 2014
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decompression Alone vs. Decompression and Instrumented Fusion for the Management of Lumbar Spinal Stenosis Associated With Stable Degenerative Spondylolisthesis: A Pragmatic Randomized Clinical Pilot Trial
- ClinicalTrials.gov ID
- NCT02348645
- Acronym / sponsor ID
- 13-6927
- Conditions
- Spinal Stenosis, Spondylolisthesis
- Keywords
- Pilot projects, Feasibility studies, Intervention studies, Orthopedics, Orthopedic Procedures, Neurosurgical Procedures, Neurosurgery, Spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Aug 2023 (actual)
- Study completion
- Aug 2023 (actual)
- First posted
- 28 Jan 2015 (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.
The purpose of this study is to assess the feasibility of a full-scale multicenter randomized, controlled trial comparing the effectiveness of two surgical treatments for a condition associated with lumbar spinal stenosis called degenerative lumbar spondylolisthesis. Both treatments are currently used, but individual surgeons use different selection criteria for each treatment and use the procedures at different rates. The two procedures are decompression with fusion (the most common surgical procedure for spondylolisthesis) and midline-sparing decompression alone (which is also a standard treatment, but is not as widely used for treating spondylolisthesis). The investigators plan to collect the evidence on the following:
- The feasibility of the trial protocol, and
- Preliminary data on the effectiveness of each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decompression with fusion | Active comparator | Procedure: Spinal fusion, Procedure: Spinal decompressionSpinal decompression surgery with instrumented spinal fusion |
| Decompression alone | Active comparator | Procedure: Spinal decompressionMidline-sparing spinal decompression alone |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients deemed to be surgical candidates with focal (1-2 level) lumbar spinal stenosis (LSS) and associated stable degenerative spondylolisthesis with the following characteristics:
- aged 50 or over
- sufficient fluency in English or French to provide informed consent and complete questionnaires with or without the need of an interpreter
Key exclusion criteria (5 listed)
- Greater than 25% listhesis or spinal instability as demonstrated by motion (>5mm of translation) on flexion extension radiographs or non-loaded (MRI/CT or supine x-rays) to loaded imaging (standing radiograph)
- Presence of kyphosis (>0 degrees at the affected level or globally), degenerative scoliosis (>10 degree using the Cobb method) with rotatory or lateral listhesis on preoperative x-rays
- Clinical history of osteoporotic fracture or chronic oral steroid use
- Previous posterior lumbar spinal surgery (excluding prior microdiscectomy)
- Patients who have evidence of neurological disorders that affect physical function (e.g. peripheral neuropathy), neuromuscular disorders (e.g. multiple sclerosis, Parkinson's etc.) or systemic illness (e.g. inflammatory arthritis) that affects physical function
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 |
|---|---|---|
| Spinal fusion | Procedure or surgery | Decompression with fusion |
| Spinal decompression | Procedure or surgery | Decompression alone, Decompression with fusion |
Primary outcome
Number of patients recruited
Time frame: 1 year
Number of eligible patients
Time frame: 1 year
Reasons for refusal to consent
Time frame: 1 year
Proportion of patients who adhere to randomized allocation
Time frame: 2 years
Number of patients refusing to consent due to blinding
Time frame: 1 year
Blinding status
Time frame: 1.5 months post-surgery
Patient's assessment of which treatment they received
Oswestry Disability Index (ODI)
Time frame: 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery
10-item patient-reported questionnaire measuring disability related to low back pain. Each item has six response options ranging from 0 to 5; the responses are summed and rescaled so 0 indicates no disability and 100 indicates extreme disability.
Proportion of patients who receive randomized allocation
Time frame: 2 years
Number of patients refusing to consent due to randomization
Time frame: 1 year
Number, type and severity of adverse events
Time frame: End of hospital stay (average 6.5 days post-surgery)
6 secondary outcomes
Short-Form 12 scores: Physical Function, Bodily Pain, Physical Component Summary
Time frame: Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery
Euro-QoL health utility index
Time frame: Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery
Patient Health Questionnaire-9 score
Time frame: Baseline
Costs incurred by patients
Time frame: monthly from 1.5 to 12 months post-surgery; 24 months post-surgery
Hospital cost
Time frame: End of hospital stay (average 6.5 days post-surgery)
Healthcare services used
Time frame: Referral to 1 year post-surgery
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 7 May 2026.
Related trials for Spinal Stenosis
Recruiting
Activity Post Spinal Surgery Engagement Trial
Spinal Surgery for Lumbar Spinal Stenosis (LSS)
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
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.
Yoga Raja Rampersaud, MD FRCSC principal investigator
University Health Network, Toronto
Anthony Perruccio, PhD principal investigator
University Health Network, Toronto
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal fusion and Spinal decompression in people with Spinal Stenosis and Spondylolisthesis, run by University Health Network, Toronto at 8 sites in Canada.
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 6 inclusion and 5 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. 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?
Number of patients recruited (time frame: 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.