Clinical trial NCT01921530: Interbody vs Instrumented Posterolateral Fusion Following Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis
Official title: Interbody Fusion and Decompression Versus Instrumented Posterolateral Fusion and Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Degenerative Spondylolisthesis
Spinal Stenosis
Keywords: Posterolateral Fusion
Interbody Fusion
Lumbar
Spinal Stenosis
Degenerative Spondylolisthesis
Lead sponsor: The London Spine Centre
Sponsor class: OTHER
First posted: 2013-08-13
Enrollment: 178
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Degenerative spondylolisthesis describes the slip of one spinal segment relative to the adjacent segment. It is usually associated with spinal stenosis (which limits one's ability to walk and stand) and is the most common indication for surgery in adults over age 65 years. A variety of surgical techniques are available; the most common are the Posterolateral Instrumented Fusion (PLF), and Interbody Fusion (IF) including Posterolateral Interbody Fusion (PLIF), and Transforaminal Interbody fusion (TLIF). IF uses a cage that is placed within the cleaned out disc space between the vertebral bodies being fused. Although this approach achieves a good fusion rate and deformity correction it is associated with a higher surgical cost and potential intra-operative complication rate. What is more, no consensus exists as to whether IF provides better patient rated functional outcome and quality of life. If the advantages of IF do not translate into superior patient rated outcomes, then the risk-benefit ratio would be tipped in favor of PLF. The purpose of this study is to determine if IF is equivalent to PLF for the treatment of degenerative spondylolisthesis. The investigators will conduct a prospective randomized control trial comparing these two procedures. Our primary outcome measure will be the Oswestry Disability Index, which evaluates spinal pain and function.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 50 years or older
2. Grade I or II (less than 50% slip of the cephalad vertebra compared to the caudal vertebra) degenerative spondylolisthesis at one or two contiguous levels between L1 and L5.
3. Lumbar spinal stenosis at the same levels of the degenerative spondylolisthesis producing radiculopathy or neurogenic claudication unresponsive to a minimum of 3 months of non surgical treatment
4. Patients who are medically suitable for surgical management
5. Patients who have consented for surgical treatment
6. Patients able to provide informed consent for the study and complete the questionnaires

Exclusion Criteria:

1. Lytic spondylolisthesis
2. Non degenerative stenosis (example: tumor, trauma, epidural lipomatosis)
3. Severe vertical foraminal stenosis necessitating interbody insertion to re-establish foraminal height
4. Segmental kyphosis at the level of the spondylolisthesis
5. Segmental scoliosis \>10 degrees at the level of the spondylolisthesis
6. Rheumatoid arthritis
7. Active infection
8. On long term disability or workers compensation claim
9. Drug or alcohol misuse
10. Lack of permanent home residence
11. Previous surgery at the proposed surgical level
12. Previous fusion in the lumbar spine
13. Contraindication to surgery: medical co morbidities
14. Unable to complete questionnaire (e.g. Dementia)
15. Unable to give voluntary consent

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 1 year post surgery
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: Enrollment, and at 6 weeks, 3 months, 6 months, 2 years, 5 years and post surgery
Other outcomes:
measure: Visual Analogue Scale for back pain intensity (0-10: 0= no pain, 10=worst pain)
timeFrame: Enrollment at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
measure: Visual Analogue Scale for leg pain intensity (0-10: 0= no pain, 10=worst pain)
timeFrame: Enrollment and at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
measure: SF-12 (General Health outcome measure)
timeFrame: Enrollment at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
measure: Patient satisfaction
timeFrame: Enrollment and at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
measure: Cost analysis
timeFrame: Enrollment, and at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
measure: Fusion rates
timeFrame: 6 months, 1 year, 5 year
measure: Intra-operative Complication rate
timeFrame: within 6 weeks after sugery
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: The London Spine Centre
name: Christopher S Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References: