Interbody vs Instrumented Posterolateral Fusion Following Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis

Phase 4

• Conditions: Degenerative Spondylolisthesis; Spinal Stenosis
• Interventions: Procedure: Posterolateral Fusion; Procedure: Interbody Fusion

• Registration Number: NCT01921530
• Lead Sponsor: The London Spine Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-09
• Study First Submitted QC: 2013-08-12
• Study First Posted: 2013-08-13
• Study Start: 2013-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-20
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Posterolateral Fusion	Posterolateral Fusion	-
Interbody Fusion	Interbody Fusion	-

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	1 year post surgery	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 a commonly utilized, validated, and highly reproducible. The questionnaire can be completed in less than 5 minutes and a large amount of normative data exists.

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index	Enrollment, and at 6 weeks, 3 months, 6 months, 2 years, 5 years and post surgery	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 a commonly utilized, validated, and highly reproducible. The questionnaire can be completed in less than 5 minutes and a large amount of normative data exists.

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada