Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion

Not Applicable

• Conditions: Degenerative Lumbar Spondylolisthesis

• 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

Study Timeline

• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-14
• Study Start: 2014-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-20
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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