Recruiting

Midline Lumbar Fusion vs. Posterior Lumbar Interbody Fusion

Sponsor:

The London Spine Centre

Code:

NCT02290314

Conditions

Degenerative Lumbar Spondylolisthesis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

minimally invasive MID-line Lumbar Fusion (MIDLF)

Posterior lumbar interbody fusion (PLIF)

Study Details

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

Study ID

NCT02290314

Start date

Dec, 2014

Status verified date

Aug, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

minimally invasive MID-line Lumbar Fusion (MIDLF)

Posterior lumbar interbody fusion (PLIF)

Primary outcome measure

  • Time to discharge [ Time Frame: Length of inhospital stay after surgery - average 4 days ]

Central Contacts and Locations

Central contacts

Locations

London Health Science Centre

Recruiting

London, Ontario, Canada, N6G 5L7

Contacts

christopher S Bailey, MD

519-685-8500chris.bailey@lhsc.on.ca

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6G 5L7

Contacts

Christopher S Bailey, MD

519-685-8500Chris.Bailey@lhsc.on.ca

Principal Investigator:

Christopher S Bailey, MD

More Information

Sponsor

The London Spine Centre

Last update posted

Aug 20, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The London Spine Centre on 2018-08-20.