Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion

Minimal Access Midline Lumbar Fusion Versus Traditional Open Posterior Lumbar Interbody Fusion for Degenerative Lumbar Spondylolisthesis

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.

Study Overview

• Status: Unknown
• Conditions: Degenerative Lumbar Spondylolisthesis
• Intervention / Treatment: Procedure: minimally invasive MID-line Lumbar Fusion (MIDLF); Procedure: Posterior lumbar interbody fusion (PLIF)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6G 5L7
      • Recruiting
      • London Health Science Centre
      • Contact: Christopher S Bailey, MD; Phone Number: 55358 519-685-8500; Email: Chris.Bailey@lhsc.on.ca
    • London, Ontario, Canada, N6G 5L7
      • Recruiting
      • London Health Sciences Centre
      • Contact: Christopher S Bailey, MD; Phone Number: 55358 519-685-8500; Email: Chris.Bailey@lhsc.on.ca
      • Principal Investigator: Christopher S Bailey, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to discharge	Length of inhospital stay after surgery - average 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Approach-related in-hospital morbidity	Blood loss, length of surgery, narcotic usage, nursing care, and adverse events will be compared between groups	At time of index surgery
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.	Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Cost-effectiveness of the two surgical approaches	Economic score and cost analysis for each procedure	Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scale for back pain intensity (0-10; 0=no pain; 10= worst pain)		Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Numeric rating scale for leg pain intensity (0-10; o=no pain; 10=worst pain)		Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
General Health outcome measure (SF12)	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	Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Patient satisfaction	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.	Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years

Collaborators and Investigators

• Sponsor: The London Spine Centre
• Investigators: Principal Investigator: Chris Bailey, London Health Sciences Centre and Western University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 7, 2014
• First Submitted That Met QC Criteria: November 10, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: 105951