Clinical trial NCT02348645: Decompression vs. Fusion for Stable Degenerative Spondylolisthesis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Stenosis
Spondylolisthesis
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
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients recruited
timeFrame: 1 year
measure: Number of eligible patients
timeFrame: 1 year
measure: Reasons for refusal to consent
timeFrame: 1 year
measure: Proportion of patients who adhere to randomized allocation
timeFrame: 2 years
measure: Number of patients refusing to consent due to blinding
timeFrame: 1 year
measure: Blinding status
timeFrame: 1.5 months post-surgery
measure: Oswestry Disability Index (ODI)
timeFrame: 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery
measure: Proportion of patients who receive randomized allocation
timeFrame: 2 years
measure: Number of patients refusing to consent due to randomization
timeFrame: 1 year
measure: Number, type and severity of adverse events
timeFrame: End of hospital stay (average 6.5 days post-surgery)
Secondary outcomes:
measure: Short-Form 12 scores: Physical Function, Bodily Pain, Physical Component Summary
timeFrame: Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery
measure: Euro-QoL health utility index
timeFrame: Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery
measure: Patient Health Questionnaire-9 score
timeFrame: Baseline
measure: Costs incurred by patients
timeFrame: monthly from 1.5 to 12 months post-surgery; 24 months post-surgery
measure: Hospital cost
timeFrame: End of hospital stay (average 6.5 days post-surgery)
measure: Healthcare services used
timeFrame: Referral to 1 year post-surgery
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: Mackenzie Health Sciences Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre - Victoria Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: University Health Network, Toronto
name: Yoga Raja Rampersaud, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Anthony Perruccio, PhD
role: PRINCIPAL_INVESTIGATOR
References: