Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion
- Conditions
- Degenerative Lumbar Spondylolisthesis
- Interventions
- Procedure: minimally invasive MID-line Lumbar Fusion (MIDLF)Procedure: Posterior lumbar interbody fusion (PLIF)
- Registration Number
- NCT02290314
- Lead Sponsor
- The London Spine Centre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Patients attending Victoria Hospital
- Degenerative spondylolisthesis in the lumbar spine at one level
- Medically Suitable for surgical management
- Able to consent for surgery
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description minimally invasive MID-line Lumbar Fusion (MIDLF) 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. posterior lumbar interbody fusion (PLIF) 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.
- Primary Outcome Measures
Name Time Method Time to discharge Length of inhospital stay after surgery - average 4 days
- Secondary Outcome Measures
Name Time Method Approach-related in-hospital morbidity At time of index surgery Blood loss, length of surgery, narcotic usage, nursing care, and adverse events will be compared between groups
Cost-effectiveness of the two surgical approaches Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years Economic score and cost analysis for each procedure
Oswestry Disability Index Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years 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.
Trial Locations
- Locations (2)
London Health Science Centre
🇨🇦London, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada