Decompression vs. Fusion for Stable Degenerative Spondylolisthesis

Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02348645
• Other study ID #: 13-6927
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2015
• Est. completion date: September 2023

Study information

• Verified date: November 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis
• Spondylolisthesis

Intervention

Procedure:
• Spinal fusion

• Spinal decompression

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Mackenzie Health Sciences Centre	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	London Health Sciences Centre - Victoria Hospital	London	Ontario
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients recruited		1 year
Primary	Number of eligible patients		1 year
Primary	Reasons for refusal to consent		1 year
Primary	Proportion of patients who adhere to randomized allocation		2 years
Primary	Number of patients refusing to consent due to blinding		1 year
Primary	Blinding status	Patient's assessment of which treatment they received	1.5 months post-surgery
Primary	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
Primary	Proportion of patients who receive randomized allocation		2 years
Primary	Number of patients refusing to consent due to randomization		1 year
Primary	Number, type and severity of adverse events		End of hospital stay (average 6.5 days post-surgery)
Secondary	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
Secondary	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
Secondary	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
Secondary	Costs incurred by patients		monthly from 1.5 to 12 months post-surgery; 24 months post-surgery
Secondary	Hospital cost		End of hospital stay (average 6.5 days post-surgery)
Secondary	Healthcare services used	Other Ontario Health Insurance Plan (OHIP)-billed services used	Referral to 1 year post-surgery