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Clinical Trials/NCT02290314
NCT02290314
Unknown
Not Applicable

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

The London Spine Centre2 sites in 1 country60 target enrollmentDecember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Degenerative Lumbar Spondylolisthesis
Sponsor
The London Spine Centre
Enrollment
60
Locations
2
Primary Endpoint
Time to discharge
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
December 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The London Spine Centre
Responsible Party
Principal Investigator
Principal Investigator

Dr. Christopher Bailey

Dr. Christopher Bailey

The London Spine Centre

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

Outcomes

Primary Outcomes

Time to discharge

Time Frame: Length of inhospital stay after surgery - average 4 days

Secondary Outcomes

  • Approach-related in-hospital morbidity(At time of index surgery)
  • Cost-effectiveness of the two surgical approaches(Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years)
  • Oswestry Disability Index(Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years)

Study Sites (2)

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