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

NCT01921530 | Unknown Phase 4

• 1 other identifier: 103386
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Spondylolisthesis; Spinal Stenosis

Keywords

Posterolateral Fusion; Interbody Fusion; Lumbar; Spinal Stenosis; Degenerative Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Oswestry Disability Index

  Enrollment, and at 6 weeks, 3 months, 6 months, 2 years, 5 years and post surgery

Other Outcomes (7)

• 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

• 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

• SF-12 (General Health outcome measure)

  Enrollment at 6 weeks, 3 months, 6 months, 1 year, 2 year, 5 year post surgery

Study Arms (2)

Interbody Fusion

ACTIVE COMPARATOR

Procedure: Interbody Fusion

Posterolateral Fusion

ACTIVE COMPARATOR

Procedure: Posterolateral Fusion

Interventions

Interbody Fusion PROCEDURE

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.

Also known as: Posterolateral Interbody Fusion (PLIF), Transforaminal Interbody fusion (TLIF)

Interbody Fusion

Posterolateral Fusion PROCEDURE

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.

Posterolateral Fusion

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 50 years or older
• 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.
• 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
• Patients who are medically suitable for surgical management
• Patients who have consented for surgical treatment
• Patients able to provide informed consent for the study and complete the questionnaires

You may not qualify if:

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

Sponsors & Collaborators

• The London Spine Centre: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6G 5L7, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Christopher S Bailey, MD

  The London Spine Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher S Bailey, MD

CONTACT

519-685-8500; Chris.Bailey@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 13, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

CA (1)