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Interbody vs Instrumented Posterolateral Fusion Following Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis

Primary Purpose

Degenerative Spondylolisthesis, Spinal Stenosis

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Interbody Fusion
Posterolateral Fusion
Sponsored by
The London Spine Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Spondylolisthesis focused on measuring Posterolateral Fusion, Interbody Fusion, Lumbar, Spinal Stenosis, Degenerative Spondylolisthesis

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients aged 50 years or older
  2. Grade I or II (less than 50% slip of the cephalad vertebra compared to the caudal vertebra) degenerative spondylolisthesis at one or two contiguous levels between L1 and L5.
  3. Lumbar spinal stenosis at the same levels of the degenerative spondylolisthesis producing radiculopathy or neurogenic claudication unresponsive to a minimum of 3 months of non surgical treatment
  4. Patients who are medically suitable for surgical management
  5. Patients who have consented for surgical treatment
  6. Patients able to provide informed consent for the study and complete the questionnaires

Exclusion Criteria:

  1. Lytic spondylolisthesis
  2. Non degenerative stenosis (example: tumor, trauma, epidural lipomatosis)
  3. Severe vertical foraminal stenosis necessitating interbody insertion to re-establish foraminal height
  4. Segmental kyphosis at the level of the spondylolisthesis
  5. Segmental scoliosis >10 degrees at the level of the spondylolisthesis
  6. Rheumatoid arthritis
  7. Active infection
  8. On long term disability or workers compensation claim
  9. Drug or alcohol misuse
  10. Lack of permanent home residence
  11. Previous surgery at the proposed surgical level
  12. Previous fusion in the lumbar spine
  13. Contraindication to surgery: medical co morbidities
  14. Unable to complete questionnaire (e.g. Dementia)
  15. Unable to give voluntary consent

Sites / Locations

  • London Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Interbody Fusion

Posterolateral Fusion

Arm Description

Outcomes

Primary Outcome Measures

Oswestry Disability Index
The Oswestry Disability Index is an effective method of measuring disability in patients with back and leg pain and is well suited to patients who have had persistent severe disability. It is a commonly utilized, validated, and highly reproducible. The questionnaire can be completed in less than 5 minutes and a large amount of normative data exists.

Secondary Outcome Measures

Oswestry Disability Index
The Oswestry Disability Index is an effective method of measuring disability in patients with back and leg pain and is well suited to patients who have had persistent severe disability. It is a commonly utilized, validated, and highly reproducible. The questionnaire can be completed in less than 5 minutes and a large amount of normative data exists.

Full Information

First Posted
August 9, 2013
Last Updated
August 17, 2018
Sponsor
The London Spine Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01921530
Brief Title
Interbody vs Instrumented Posterolateral Fusion Following Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis
Official Title
Interbody Fusion and Decompression Versus Instrumented Posterolateral Fusion and Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The London Spine Centre

4. Oversight

5. Study Description

Brief Summary
Degenerative spondylolisthesis describes the slip of one spinal segment relative to the adjacent segment. It is usually associated with spinal stenosis (which limits one's ability to walk and stand) and is the most common indication for surgery in adults over age 65 years. A variety of surgical techniques are available; the most common are the Posterolateral Instrumented Fusion (PLF), and Interbody Fusion (IF) including Posterolateral Interbody Fusion (PLIF), and Transforaminal Interbody fusion (TLIF). IF uses a cage that is placed within the cleaned out disc space between the vertebral bodies being fused. Although this approach achieves a good fusion rate and deformity correction it is associated with a higher surgical cost and potential intra-operative complication rate. What is more, no consensus exists as to whether IF provides better patient rated functional outcome and quality of life. If the advantages of IF do not translate into superior patient rated outcomes, then the risk-benefit ratio would be tipped in favor of PLF. The purpose of this study is to determine if IF is equivalent to PLF for the treatment of degenerative spondylolisthesis. The investigators will conduct a prospective randomized control trial comparing these two procedures. Our primary outcome measure will be the Oswestry Disability Index, which evaluates spinal pain and function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Spondylolisthesis, Spinal Stenosis
Keywords
Posterolateral Fusion, Interbody Fusion, Lumbar, Spinal Stenosis, Degenerative Spondylolisthesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interbody Fusion
Arm Type
Active Comparator
Arm Title
Posterolateral Fusion
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Interbody Fusion
Other Intervention Name(s)
Posterolateral Interbody Fusion (PLIF), Transforaminal Interbody fusion (TLIF)
Intervention Description
The interbody fusion (IF) procedure requires exposure and removal of the disc, curetting the end plates, inserting a cage filled with bone graft, as well as stabilization with rods and screws.
Intervention Type
Procedure
Intervention Name(s)
Posterolateral Fusion
Intervention Description
In posterolateral fusion stabilization is achieved using pedicle screws joined by rods. The graft used to facilitate fusion is placed between decorticated transverse processes and can be an autograft of iliac bone or local bone, allograft, or a synthetic expander.
Primary Outcome Measure Information:
Title
Oswestry Disability Index
Description
The Oswestry Disability Index is an effective method of measuring disability in patients with back and leg pain and is well suited to patients who have had persistent severe disability. It is a commonly utilized, validated, and highly reproducible. The questionnaire can be completed in less than 5 minutes and a large amount of normative data exists.
Time Frame
1 year post surgery
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
The Oswestry Disability Index is an effective method of measuring disability in patients with back and leg pain and is well suited to patients who have had persistent severe disability. It is a commonly utilized, validated, and highly reproducible. The questionnaire can be completed in less than 5 minutes and a large amount of normative data exists.
Time Frame
Enrollment, and at 6 weeks, 3 months, 6 months, 2 years, 5 years and post surgery
Other Pre-specified Outcome Measures:
Title
Visual Analogue Scale for back pain intensity (0-10: 0= no pain, 10=worst pain)
Time Frame
Enrollment at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
Title
Visual Analogue Scale for leg pain intensity (0-10: 0= no pain, 10=worst pain)
Time Frame
Enrollment and at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
Title
SF-12 (General Health outcome measure)
Description
The SF-12 is a standardized health related quality of life outcome questionnaire, which assess 8 health domains. The physical and mental component can be derived. It has been shown to be valid and reliable when applied to the spine patient population.
Time Frame
Enrollment at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
Title
Patient satisfaction
Description
"All things considered, how satisfied are you with the results of your recent treatment for your spine fracture? 1-7, 8= not sure." This sentence is the recommended tool for assessing global satisfaction.
Time Frame
Enrollment and at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
Title
Cost analysis
Description
Prolo economic score and cost analysis for each procedure
Time Frame
Enrollment, and at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
Title
Fusion rates
Time Frame
6 months, 1 year, 5 year
Title
Intra-operative Complication rate
Time Frame
within 6 weeks after sugery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 50 years or older Grade I or II (less than 50% slip of the cephalad vertebra compared to the caudal vertebra) degenerative spondylolisthesis at one or two contiguous levels between L1 and L5. Lumbar spinal stenosis at the same levels of the degenerative spondylolisthesis producing radiculopathy or neurogenic claudication unresponsive to a minimum of 3 months of non surgical treatment Patients who are medically suitable for surgical management Patients who have consented for surgical treatment Patients able to provide informed consent for the study and complete the questionnaires Exclusion Criteria: Lytic spondylolisthesis Non degenerative stenosis (example: tumor, trauma, epidural lipomatosis) Severe vertical foraminal stenosis necessitating interbody insertion to re-establish foraminal height Segmental kyphosis at the level of the spondylolisthesis Segmental scoliosis >10 degrees at the level of the spondylolisthesis Rheumatoid arthritis Active infection On long term disability or workers compensation claim Drug or alcohol misuse Lack of permanent home residence Previous surgery at the proposed surgical level Previous fusion in the lumbar spine Contraindication to surgery: medical co morbidities Unable to complete questionnaire (e.g. Dementia) Unable to give voluntary consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher S Bailey, MD
Phone
519-685-8500
Ext
55358
Email
Chris.Bailey@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher S Bailey, MD
Organizational Affiliation
The London Spine Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 5L7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher S Bailey, MD
Phone
519-685-8500
Ext
55358
Email
Chris.Bailey@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Christopher S Bailey, MD

12. IPD Sharing Statement

Learn more about this trial

Interbody vs Instrumented Posterolateral Fusion Following Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis

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