Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion

NCT02290314 | Unknown DMC

• 1 other identifier: 105951
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Degenerative Lumbar Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• Time to discharge

  Length of inhospital stay after surgery - average 4 days

Secondary Outcomes (3)

• Approach-related in-hospital morbidity

  At time of index surgery

• Oswestry Disability Index

  Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years

• Cost-effectiveness of the two surgical approaches

  Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years

Other Outcomes (4)

• 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)

  Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years

Study Arms (2)

minimally invasive MID-line Lumbar Fusion (MIDLF)

OTHER

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)

OTHER

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)

Interventions

minimally invasive MID-line Lumbar Fusion (MIDLF) PROCEDURE

minimally invasive MID-line Lumbar Fusion (MIDLF)

Posterior lumbar interbody fusion (PLIF) PROCEDURE

posterior lumbar interbody fusion (PLIF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The London Spine Centre: lead

Study Sites (2)

London Health Science Centre

London, Ontario, N6G 5L7, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6G 5L7, Canada

RECRUITING

Study Officials

• Chris Bailey

  London Health Sciences Centre and Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Urquhart

CONTACT

5196858500; jennifer.urquhart@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Christopher Bailey

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 14, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

CA (2)