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Decompression vs. Fusion for Stable Degenerative Spondylolisthesis

Primary Purpose

Spinal Stenosis, Spondylolisthesis

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Spinal fusion
Spinal decompression
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis focused on measuring 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

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foothills Medical Centre
  • Mackenzie Health Sciences Centre
  • Vancouver General Hospital
  • Queen Elizabeth II Health Sciences Centre
  • London Health Sciences Centre - Victoria Hospital
  • Sunnybrook Health Sciences Centre
  • University Health Network
  • Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Decompression with fusion

Decompression alone

Arm Description

Spinal decompression surgery with instrumented spinal fusion

Midline-sparing spinal decompression alone

Outcomes

Primary Outcome Measures

Number of patients recruited
Number of eligible patients
Reasons for refusal to consent
Proportion of patients who adhere to randomized allocation
Number of patients refusing to consent due to blinding
Blinding status
Patient's assessment of which treatment they received
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.
Proportion of patients who receive randomized allocation
Number of patients refusing to consent due to randomization
Number, type and severity of adverse events

Secondary Outcome Measures

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.
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).
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.
Costs incurred by patients
Hospital cost
Healthcare services used
Other Ontario Health Insurance Plan (OHIP)-billed services used

Full Information

First Posted
September 9, 2014
Last Updated
November 4, 2022
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02348645
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2015 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decompression with fusion
Arm Type
Active Comparator
Arm Description
Spinal decompression surgery with instrumented spinal fusion
Arm Title
Decompression alone
Arm Type
Active Comparator
Arm Description
Midline-sparing spinal decompression alone
Intervention Type
Procedure
Intervention Name(s)
Spinal fusion
Intervention Type
Procedure
Intervention Name(s)
Spinal decompression
Primary Outcome Measure Information:
Title
Number of patients recruited
Time Frame
1 year
Title
Number of eligible patients
Time Frame
1 year
Title
Reasons for refusal to consent
Time Frame
1 year
Title
Proportion of patients who adhere to randomized allocation
Time Frame
2 years
Title
Number of patients refusing to consent due to blinding
Time Frame
1 year
Title
Blinding status
Description
Patient's assessment of which treatment they received
Time Frame
1.5 months post-surgery
Title
Oswestry Disability Index (ODI)
Description
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
Title
Proportion of patients who receive randomized allocation
Time Frame
2 years
Title
Number of patients refusing to consent due to randomization
Time Frame
1 year
Title
Number, type and severity of adverse events
Time Frame
End of hospital stay (average 6.5 days post-surgery)
Secondary Outcome Measure Information:
Title
Short-Form 12 scores: Physical Function, Bodily Pain, Physical Component Summary
Description
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
Title
Euro-QoL health utility index
Description
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
Title
Patient Health Questionnaire-9 score
Description
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
Title
Costs incurred by patients
Time Frame
monthly from 1.5 to 12 months post-surgery; 24 months post-surgery
Title
Hospital cost
Time Frame
End of hospital stay (average 6.5 days post-surgery)
Title
Healthcare services used
Description
Other Ontario Health Insurance Plan (OHIP)-billed services used
Time Frame
Referral to 1 year post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoga Raja Rampersaud, MD FRCSC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anthony Perruccio, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2N9
Country
Canada
Facility Name
Mackenzie Health Sciences Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
London Health Sciences Centre - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

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Decompression vs. Fusion for Stable Degenerative Spondylolisthesis

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