Decompression vs. Fusion for Stable Degenerative Spondylolisthesis

Not Applicable

Active, not recruiting

• Conditions: Spinal Stenosis; Spondylolisthesis
• Interventions: Procedure: Spinal fusion; Procedure: Spinal decompression

• Registration Number: NCT02348645
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-28
• Study Start: 2015-07
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-09
• Primary Completion: 2023-06
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decompression with fusion	Spinal fusion	Spinal decompression surgery with instrumented spinal fusion
Decompression with fusion	Spinal decompression	Spinal decompression surgery with instrumented spinal fusion
Decompression alone	Spinal decompression	Midline-sparing spinal decompression alone

Primary Outcome Measures

Name	Time	Method
Number of eligible patients	1 year
Proportion of patients who receive randomized allocation	2 years
Proportion of patients who adhere to randomized allocation	2 years
Number of patients refusing to consent due to randomization	1 year
Reasons for refusal to consent	1 year
Number, type and severity of adverse events	End of hospital stay (average 6.5 days post-surgery)
Number of patients recruited	1 year
Number of patients refusing to consent due to blinding	1 year
Blinding status	1.5 months post-surgery	Patient's assessment of which treatment they received
Oswestry Disability Index (ODI)	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.

Secondary Outcome Measures

Name	Time	Method
Costs incurred by patients	monthly from 1.5 to 12 months post-surgery; 24 months post-surgery
Short-Form 12 scores: Physical Function, Bodily Pain, Physical Component Summary	Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery	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.
Patient Health Questionnaire-9 score	Baseline	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.
Euro-QoL health utility index	Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery	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).
Hospital cost	End of hospital stay (average 6.5 days post-surgery)
Healthcare services used	Referral to 1 year post-surgery	Other Ontario Health Insurance Plan (OHIP)-billed services used

Trial Locations

Locations (8)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

London Health Sciences Centre - Victoria Hospital; 🇨🇦 London, Ontario, Canada

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada

Mackenzie Health Sciences Centre; 🇨🇦 Edmonton, Alberta, Canada

Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada