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Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion

Primary Purpose

Degenerative Lumbar Spondylolisthesis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
minimally invasive MID-line Lumbar Fusion (MIDLF)
Posterior lumbar interbody fusion (PLIF)
Sponsored by
The London Spine Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Lumbar Spondylolisthesis

Eligibility Criteria

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

Inclusion Criteria:

  • Patients attending Victoria Hospital
  • Degenerative spondylolisthesis in the lumbar spine at one level
  • Medically Suitable for surgical management
  • Able to consent for surgery

Exclusion Criteria:

  • Lytic spondylolisthesis
  • Non degenerative stenosis: tumor, trauma
  • Active infection
  • On long term disability or workers compensation claims
  • Drug or alcohol misuse
  • Lack of permanent home residence
  • Previous surgery in the lumbar spine at the surgical level
  • Previous fusion in the lumbar spine
  • Contraindication to surgery: medical co morbidities
  • Unable to complete questionnaire: eg dementia
  • Unable to give voluntary consent
  • Pregnant

Sites / Locations

  • London Health Science CentreRecruiting
  • London Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

minimally invasive MID-line Lumbar Fusion (MIDLF)

posterior lumbar interbody fusion (PLIF)

Arm Description

MIDLF surgery involves a minimally invasive midline laminectomy posterior approach to the lumbar spine. An incision that is smaller than the standard incision is made in the midline of the low back directly over the spinal levels. Afterward the pressure on the compressed nerves is released, and the disc between the affected vertebrae is completely removed. A metal cage filled with bone graft is placed as described in the PLIF procedure.

PLIF surgery involves a standard incision in the midline of the low back directly over the involved spinal levels. Afterward the pressure on the compressed nerves is released, and the disc between the affected vertebrae is completely removed. A metal cage filled with bone graft is placed in between the vertebral bodies where the disc usually lies. This will allow bone fusion (healing) to occur from one vertebral body to the other.

Outcomes

Primary Outcome Measures

Time to discharge

Secondary Outcome Measures

Approach-related in-hospital morbidity
Blood loss, length of surgery, narcotic usage, nursing care, and adverse events will be compared between groups
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 commonly utilized, validated and highly reproducible.
Cost-effectiveness of the two surgical approaches
Economic score and cost analysis for each procedure

Full Information

First Posted
November 7, 2014
Last Updated
August 17, 2018
Sponsor
The London Spine Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02290314
Brief Title
Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion
Official Title
Minimal Access Midline Lumbar Fusion Versus Traditional Open Posterior Lumbar Interbody Fusion for Degenerative Lumbar Spondylolisthesis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Degenerative lumbar spondylolisthesis is the forward displacement (slip) of one vertebra on an adjacent vertebra resulting in narrowing of the spinal canal or compression of the exiting nerve roots. It is commonly associated with low back and leg pain, and is a frequent reason for spine surgery particularly in individuals over age 65 years. Recently novel minimally invasive surgical techniques have heightened public and government interest by touting benefits of reduced approached-related morbidity which in turn leads to quicker recovery, shorter hospital stay, improved short-term clinical outcomes, and reduced health care cost. However, there is no randomized controlled trial evidence to describe the actual advantages and disadvantages associated with minimally invasive spinal fusion. This pilot study is a randomized control trial comparing minimally invasive MID-line Lumbar Fusion (MIDLF) to traditional "open" posterior lumbar interbody fusion (PLIF) with respect to length of stay, approach related morbidity, patient centered outcome measures, and cost-effectiveness in the treatment of degenerative lumbar spondylolisthesis.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
minimally invasive MID-line Lumbar Fusion (MIDLF)
Arm Type
Other
Arm Description
MIDLF surgery involves a minimally invasive midline laminectomy posterior approach to the lumbar spine. An incision that is smaller than the standard incision is made in the midline of the low back directly over the spinal levels. Afterward the pressure on the compressed nerves is released, and the disc between the affected vertebrae is completely removed. A metal cage filled with bone graft is placed as described in the PLIF procedure.
Arm Title
posterior lumbar interbody fusion (PLIF)
Arm Type
Other
Arm Description
PLIF surgery involves a standard incision in the midline of the low back directly over the involved spinal levels. Afterward the pressure on the compressed nerves is released, and the disc between the affected vertebrae is completely removed. A metal cage filled with bone graft is placed in between the vertebral bodies where the disc usually lies. This will allow bone fusion (healing) to occur from one vertebral body to the other.
Intervention Type
Procedure
Intervention Name(s)
minimally invasive MID-line Lumbar Fusion (MIDLF)
Intervention Type
Procedure
Intervention Name(s)
Posterior lumbar interbody fusion (PLIF)
Primary Outcome Measure Information:
Title
Time to discharge
Time Frame
Length of inhospital stay after surgery - average 4 days
Secondary Outcome Measure Information:
Title
Approach-related in-hospital morbidity
Description
Blood loss, length of surgery, narcotic usage, nursing care, and adverse events will be compared between groups
Time Frame
At time of index surgery
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 commonly utilized, validated and highly reproducible.
Time Frame
Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Title
Cost-effectiveness of the two surgical approaches
Description
Economic score and cost analysis for each procedure
Time Frame
Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Other Pre-specified Outcome Measures:
Title
Numeric rating scale for back pain intensity (0-10; 0=no pain; 10= worst pain)
Time Frame
Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Title
Numeric rating scale for leg pain intensity (0-10; o=no pain; 10=worst pain)
Time Frame
Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Title
General Health outcome measure (SF12)
Description
The SF12 is a standardized health related quality of life outcome questionnaire, which assesses 8 health domains. The physical and mental component can be derived. It has been validated and reliable when applied to the spine patient population
Time Frame
Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Title
Patient satisfaction
Description
All things considered, how satisfied are you with the results of your recent treatment for your spine condition 1-7. This sentence is the recommended tool for assessing global satisfaction.
Time Frame
Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients attending Victoria Hospital Degenerative spondylolisthesis in the lumbar spine at one level Medically Suitable for surgical management Able to consent for surgery Exclusion Criteria: Lytic spondylolisthesis Non degenerative stenosis: tumor, trauma Active infection On long term disability or workers compensation claims Drug or alcohol misuse Lack of permanent home residence Previous surgery in the lumbar spine at the surgical level Previous fusion in the lumbar spine Contraindication to surgery: medical co morbidities Unable to complete questionnaire: eg dementia Unable to give voluntary consent Pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Urquhart
Phone
5196858500
Ext
53062
Email
jennifer.urquhart@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Bailey
Organizational Affiliation
London Health Sciences Centre and Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Science 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
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

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Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion

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