Decompression vs. Fusion for Stable Degenerative Spondylolisthesis

University Health Network, Toronto70 enrolled

Overview

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: 1. The feasibility of the trial protocol, and 2. Preliminary data on the effectiveness of each treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Spinal Stenosis Spondylolisthesis

Interventions

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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: 1. a clinical history of back, buttock and leg pain with walking or standing that is improved when lying, sitting or bending forward 2. a clinical history of leg symptoms that are greater than or equal to back symptoms with walking or standing, and 3. 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

Locations (8)

Foothills Medical Centre

Calgary, Alberta, Canada

Mackenzie Health Sciences Centre

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

London Health Sciences Centre - Victoria Hospital

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Montreal General Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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

Patient's assessment of which treatment they received

Time frame: 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.

Time frame: 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery

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)

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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.

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

Other Ontario Health Insurance Plan (OHIP)-billed services used

Time frame: Referral to 1 year post-surgery