Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02290314
• Date of registration: 07/11/2014
• Prospective Registration: Yes
• Primary sponsor: The London Spine Centre
• Public title: Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion
• Scientific title: Minimal Access Midline Lumbar Fusion Versus Traditional Open Posterior Lumbar Interbody Fusion for Degenerative Lumbar Spondylolisthesis
• Date of first enrolment: December 2014
• Target sample size: 60
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02290314
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Jennifer Urquhart

• Name: Chris Bailey
• Affiliation: London Health Sciences Centre and Western University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Degenerative Lumbar Spondylolisthesis

Intervention(s)

Procedure: Posterior lumbar interbody fusion (PLIF)

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

Primary Outcome(s)

Time to discharge [Time Frame: Length of inhospital stay after surgery - average 4 days]

Secondary Outcome(s)

Oswestry Disability Index [Time Frame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years]

Approach-related in-hospital morbidity [Time Frame: At time of index surgery]

Cost-effectiveness of the two surgical approaches [Time Frame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years]

Secondary ID(s)

105951

Source(s) of Monetary Support

Please refer to primary and secondary sponsors