Decompression vs. Fusion for Stable Degenerative Spondylolisthesis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Spinal Stenosis, Spondylolisthesis

Intervention / Treatment
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* Procedure: Spinal fusion
* Procedure: Spinal decompression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Decompression with fusion<br>Spinal decompression surgery with instrumented spinal fusion | Procedure: Spinal fusion<br> <br> Procedure: Spinal decompression<br> <br> |
| Active Comparator: Decompression alone<br>Midline-sparing spinal decompression alone | Procedure: Spinal decompression<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients recruited |  | 1 year | 
| Number of eligible patients |  | 1 year | 
| Reasons for refusal to consent |  | 1 year | 
| Proportion of patients who adhere to randomized allocation |  | 2 years | 
| Number of patients refusing to consent due to blinding |  | 1 year | 
| Blinding status | Patient's assessment of which treatment they received | 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. | 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery | 
| Proportion of patients who receive randomized allocation |  | 2 years | 
| Number of patients refusing to consent due to randomization |  | 1 year | 
| Number, type and severity of adverse events |  | End of hospital stay (average 6.5 days post-surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | Baseline | 
| Costs incurred by patients |  | monthly from 1.5 to 12 months post-surgery; 24 months post-surgery | 
| Hospital cost |  | End of hospital stay (average 6.5 days post-surgery) | 
| Healthcare services used | Other Ontario Health Insurance Plan (OHIP)-billed services used | Referral to 1 year post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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