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Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion

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ClinicalTrials.gov Identifier: NCT02290314
Recruitment Status : Recruiting
First Posted : November 14, 2014
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Christopher Bailey, The London Spine Centre

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.

Condition or disease Intervention/treatment Phase
Degenerative Lumbar Spondylolisthesis Procedure: minimally invasive MID-line Lumbar Fusion (MIDLF) Procedure: Posterior lumbar interbody fusion (PLIF) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minimal Access Midline Lumbar Fusion Versus Traditional Open Posterior Lumbar Interbody Fusion for Degenerative Lumbar Spondylolisthesis
Actual Study Start Date : December 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
minimally invasive MID-line Lumbar Fusion (MIDLF)
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.
Procedure: minimally invasive MID-line Lumbar Fusion (MIDLF)
posterior lumbar interbody fusion (PLIF)
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.
Procedure: Posterior lumbar interbody fusion (PLIF)



Primary Outcome Measures :
  1. Time to discharge [ Time Frame: Length of inhospital stay after surgery - average 4 days ]

Secondary Outcome Measures :
  1. Approach-related in-hospital morbidity [ Time Frame: At time of index surgery ]
    Blood loss, length of surgery, narcotic usage, nursing care, and adverse events will be compared between groups

  2. Oswestry Disability Index [ Time Frame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years ]
    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.

  3. Cost-effectiveness of the two surgical approaches [ Time Frame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years ]
    Economic score and cost analysis for each procedure


Other Outcome Measures:
  1. 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 ]
  2. 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 ]
  3. General Health outcome measure (SF12) [ Time Frame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years ]
    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

  4. Patient satisfaction [ Time Frame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290314


Contacts
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Contact: Jennifer Urquhart 5196858500 ext 53062 jennifer.urquhart@lhsc.on.ca

Locations
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Canada, Ontario
London Health Science Centre Recruiting
London, Ontario, Canada, N6G 5L7
Contact: christopher S Bailey, MD    519-685-8500 ext 55358    chris.bailey@lhsc.on.ca   
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6G 5L7
Contact: Christopher S Bailey, MD    519-685-8500 ext 55358    Chris.Bailey@lhsc.on.ca   
Principal Investigator: Christopher S Bailey, MD         
Sponsors and Collaborators
The London Spine Centre
Investigators
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Principal Investigator: Chris Bailey London Health Sciences Centre and Western University

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Responsible Party: Dr. Christopher Bailey, The London Spine Centre
ClinicalTrials.gov Identifier: NCT02290314     History of Changes
Other Study ID Numbers: 105951
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases