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

Spinal Stenosis Clinical Trial

Official title:

Interbody Fusion and Decompression Versus Instrumented Posterolateral Fusion and Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01921530
• Other study ID #: 103386
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2013
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: The London Spine Centre
• Contact: Christopher S Bailey, MD
• Phone: 519-685-8500
• Email: Chris.Bailey[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Degenerative Spondylolisthesis
• Spinal Stenosis
• Spondylolisthesis

Intervention

Procedure:
• Interbody Fusion
The interbody fusion (IF) procedure requires exposure and removal of the disc, curetting the end plates, inserting a cage filled with bone graft, as well as stabilization with rods and screws.
• Posterolateral Fusion
In posterolateral fusion stabilization is achieved using pedicle screws joined by rods. The graft used to facilitate fusion is placed between decorticated transverse processes and can be an autograft of iliac bone or local bone, allograft, or a synthetic expander.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The London Spine Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Analogue Scale for back pain intensity (0-10: 0= no pain, 10=worst pain)		Enrollment at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
Other	Visual Analogue Scale for leg pain intensity (0-10: 0= no pain, 10=worst pain)		Enrollment and at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
Other	SF-12 (General Health outcome measure)	The SF-12 is a standardized health related quality of life outcome questionnaire, which assess 8 health domains. The physical and mental component can be derived. It has been shown to be valid and reliable when applied to the spine patient population.	Enrollment at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
Other	Patient satisfaction	"All things considered, how satisfied are you with the results of your recent treatment for your spine fracture? 1-7, 8= not sure." This sentence is the recommended tool for assessing global satisfaction.	Enrollment and at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
Other	Cost analysis	Prolo economic score and cost analysis for each procedure	Enrollment, and at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery
Other	Fusion rates		6 months, 1 year, 5 year
Other	Intra-operative Complication rate		within 6 weeks after sugery
Primary	Oswestry Disability Index	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.	1 year post surgery
Secondary	Oswestry Disability Index	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.	Enrollment, and at 6 weeks, 3 months, 6 months, 2 years, 5 years and post surgery