Recruiting

Interbody vs. Instrumented

Sponsor:

The London Spine Centre

Code:

NCT01921530

Conditions

Degenerative Spondylolisthesis

Spinal Stenosis

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Interbody Fusion

Posterolateral Fusion

Study Details

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 ID

NCT01921530

Start date

Dec, 2013

Status verified date

Aug, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Enrollment

178 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Interbody Fusion

active comparator: Posterolateral Fusion

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.

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.

Primary outcome measure

  • Oswestry Disability Index [ Time Frame: 1 year post surgery ]

Central Contacts and Locations

Central contacts

Christopher S Bailey, MD

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

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6G 5L7

Contacts

Christopher S Bailey, MD

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

Principal Investigator:

Christopher S Bailey, MD

More Information

Sponsor

The London Spine Centre

Last update posted

Aug 20, 2018

Last verified

Aug, 2018

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The London Spine Centre on 2018-08-20.