Degenerative Lumbar Spondylolisthesis
Conditions
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.
Interventions
PROCEDUREminimally invasive MID-line Lumbar Fusion (MIDLF)
Sponsors
The London Spine Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to discharge | Length of inhospital stay after surgery - average 4 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| General Health outcome measure (SF12) | Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years | 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 |
| Patient satisfaction | Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years | 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. |
Countries
Canada
Contacts
Primary ContactJennifer Urquhart
Outcome results
None listed