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

This study is currently recruiting participants.
Verified March 2017 by The London Spine Centre
Sponsor:
ClinicalTrials.gov Identifier:
NCT01921530
First Posted: August 13, 2013
Last Update Posted: March 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
The London Spine Centre
  Purpose
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.

Condition Intervention Phase
Degenerative Spondylolisthesis Spinal Stenosis Procedure: Interbody Fusion Procedure: Posterolateral Fusion Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interbody Fusion and Decompression Versus Instrumented Posterolateral Fusion and Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis

Resource links provided by NLM:


Further study details as provided by The London Spine Centre:

Primary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 1 year post surgery ]
    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 [ Time Frame: Enrollment, and at 6 weeks, 3 months, 6 months, 2 years, 5 years and post surgery ]
    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.


Other Outcome Measures:
  • 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 ]
  • 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 ]
  • SF-12 (General Health outcome measure) [ Time Frame: Enrollment at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery ]
    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.

  • Patient satisfaction [ Time Frame: Enrollment and at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery ]
    "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.

  • Cost analysis [ Time Frame: Enrollment, and at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery ]
    Prolo economic score and cost analysis for each procedure

  • Fusion rates [ Time Frame: 6 months, 1 year, 5 year ]
  • Intra-operative Complication rate [ Time Frame: within 6 weeks after sugery ]

Estimated Enrollment: 178
Study Start Date: December 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Interbody Fusion Procedure: Interbody Fusion
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.
Other Names:
  • Posterolateral Interbody Fusion (PLIF)
  • Transforaminal Interbody fusion (TLIF)
Active Comparator: Posterolateral Fusion Procedure: Posterolateral Fusion
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01921530


Contacts
Contact: Christopher S Bailey, MD 519-685-8500 ext 55358 Chris.Bailey@lhsc.on.ca

Locations
Canada, Ontario
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
Principal Investigator: Christopher S Bailey, MD The London Spine Centre
  More Information

Responsible Party: The London Spine Centre
ClinicalTrials.gov Identifier: NCT01921530     History of Changes
Other Study ID Numbers: 103386
First Submitted: August 9, 2013
First Posted: August 13, 2013
Last Update Posted: March 8, 2017
Last Verified: March 2017

Keywords provided by The London Spine Centre:
Posterolateral Fusion
Interbody Fusion
Lumbar
Spinal Stenosis
Degenerative Spondylolisthesis

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Spondylolisthesis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis