Clinical trial NCT02290314: Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion
Official title: Minimal Access Midline Lumbar Fusion Versus Traditional Open Posterior Lumbar Interbody Fusion for Degenerative Lumbar Spondylolisthesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Degenerative Lumbar Spondylolisthesis
Lead sponsor: The London Spine Centre
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to discharge
timeFrame: Length of inhospital stay after surgery - average 4 days
Secondary outcomes:
measure: Approach-related in-hospital morbidity
timeFrame: At time of index surgery
measure: Oswestry Disability Index
timeFrame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
measure: Cost-effectiveness of the two surgical approaches
timeFrame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Other outcomes:
measure: Numeric rating scale for back pain intensity (0-10; 0=no pain; 10= worst pain)
timeFrame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
measure: Numeric rating scale for leg pain intensity (0-10; o=no pain; 10=worst pain)
timeFrame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
measure: General Health outcome measure (SF12)
timeFrame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
measure: Patient satisfaction
timeFrame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Locations:
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre and Western University
name: Chris Bailey
role: PRINCIPAL_INVESTIGATOR
References: