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

NCT ID: NCT01921530

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2019-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interbody Fusion

Group Type: ACTIVE_COMPARATOR

Interbody Fusion

Intervention Type: 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.

Posterolateral Fusion

Group Type: ACTIVE_COMPARATOR

Posterolateral Fusion

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Posterolateral Interbody Fusion (PLIF); Transforaminal Interbody fusion (TLIF)

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The London Spine Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher S Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

The London Spine Centre

Locations

London Health Sciences Centre

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Christopher S Bailey, MD

Role: CONTACT

Chris.Bailey@lhsc.on.ca

519-685-8500 ext. 55358

Facility Contacts

Christopher S Bailey, MD

Role: primary

Chris.Bailey@lhsc.on.ca

519-685-8500 ext. 55358

Other Identifiers

103386

Identifier Type: -

Identifier Source: org_study_id