Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion

The London Spine Centre

Status: Unknown

Conditions: Degenerative Lumbar Spondylolisthesis

Treatments: Procedure: Posterior lumbar interbody fusion (PLIF); Procedure: minimally invasive MID-line Lumbar Fusion (MIDLF)

Study type: Interventional

Funder types: Other

Identifiers

NCT02290314

105951

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

minimally invasive MID-line Lumbar Fusion (MIDLF)

Other group

Description:

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.

Treatment:

Procedure: minimally invasive MID-line Lumbar Fusion (MIDLF)

posterior lumbar interbody fusion (PLIF)

Other group

Description:

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.

Treatment:

Procedure: Posterior lumbar interbody fusion (PLIF)