Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Degenerative Lumbar Spondylolisthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

minimally invasive MID-line Lumbar Fusion (MIDLF)

Intervention Type PROCEDURE

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.

Group Type OTHER

Posterior lumbar interbody fusion (PLIF)

Intervention Type PROCEDURE

Interventions

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minimally invasive MID-line Lumbar Fusion (MIDLF)

Intervention Type PROCEDURE

Posterior lumbar interbody fusion (PLIF)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No