Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion

Degenerative Lumbar Spondylolisthesis Clinical Trial

Official title:

Minimal Access Midline Lumbar Fusion Versus Traditional Open Posterior Lumbar Interbody Fusion for Degenerative Lumbar Spondylolisthesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02290314
• Other study ID #: 105951
• Status: Recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: The London Spine Centre
• Contact: Jennifer Urquhart
• Phone: 5196858500
• Email: jennifer.urquhart[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Lumbar Spondylolisthesis
• Spondylolisthesis

Intervention

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

• Posterior lumbar interbody fusion (PLIF)

Locations

Country	Name	City	State
Canada	London Health Science Centre	London	Ontario
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The London Spine Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Numeric rating scale for back pain intensity (0-10; 0=no pain; 10= worst pain)		Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Other	Numeric rating scale for leg pain intensity (0-10; o=no pain; 10=worst pain)		Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Other	General Health outcome measure (SF12)	The SF12 is a standardized health related quality of life outcome questionnaire, which assesses 8 health domains. The physical and mental component can be derived. It has been validated and reliable when applied to the spine patient population	Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Other	Patient satisfaction	All things considered, how satisfied are you with the results of your recent treatment for your spine condition 1-7. This sentence is the recommended tool for assessing global satisfaction.	Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Primary	Time to discharge		Length of inhospital stay after surgery - average 4 days
Secondary	Approach-related in-hospital morbidity	Blood loss, length of surgery, narcotic usage, nursing care, and adverse events will be compared between groups	At time of index surgery
Secondary	Oswestry Disability Index	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.	Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Secondary	Cost-effectiveness of the two surgical approaches	Economic score and cost analysis for each procedure	Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years