Degenerative SpondylolisthesisPhase 4NCT01921530
Interbody vs Instrumented Posterolateral Fusion Following Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis
A Phase 4 study testing Interbody Fusion and Posterolateral Fusion in people with Degenerative Spondylolisthesis and Spinal Stenosis, run by The London Spine Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Degenerative Spondylolisthesis, Spinal Stenosis
- What is being tested?
- Interbody Fusion and Posterolateral Fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6G 5L7
Christopher S Bailey, MD, 519-685-8500 ext. 55358, Chris.Bailey@lhsc.on.ca
Christopher S Bailey, MD
About this study
Official title: Interbody Fusion and Decompression Versus Instrumented Posterolateral Fusion and Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis
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
- Being tested
- Interbody Fusion, Posterolateral Fusion
- Keywords
- Posterolateral Fusion, Interbody Fusion, Lumbar, Spinal Stenosis, Degenerative Spondylolisthesis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interbody FusionProcedure or surgery
Also called Posterolateral Interbody Fusion (PLIF), Transforaminal Interbody fusion (TLIF)
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 FusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Interbody Fusion | Active comparator | Not described Receives: Procedure: Interbody Fusion |
| Posterolateral Fusion | Active comparator | Not described Receives: Procedure: Posterolateral Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post surgery
Secondary 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.
Measured: Enrollment, and at 6 weeks, 3 months, 6 months, 2 years, 5 years and post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative SpondylolisthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The London Spine Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher S Bailey, MD, Principal investigator, The London Spine Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921530
- Sponsor's protocol ID
- 103386
- Status last verified
- Aug 2018
- First submitted
- 9 Aug 2013
- Last updated
- 20 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interbody Fusion and Decompression Versus Instrumented Posterolateral Fusion and Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis
- ClinicalTrials.gov ID
- NCT01921530
- Acronym / sponsor ID
- 103386
- Conditions
- Degenerative Spondylolisthesis, Spinal Stenosis
- Keywords
- Posterolateral Fusion, Interbody Fusion, Lumbar, Spinal Stenosis, Degenerative Spondylolisthesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- The London Spine CentreUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interbody Fusion | Active comparator | Procedure: Interbody Fusion |
| Posterolateral Fusion | Active comparator | Procedure: Posterolateral Fusion |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interbody FusionAlso: Posterolateral Interbody Fusion (PLIF), Transforaminal Interbody fusion (TLIF)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. | Procedure or surgery | Interbody Fusion |
| Posterolateral FusionIn 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. | Procedure or surgery | Posterolateral Fusion |
Primary outcome
Oswestry Disability Index
Time frame: 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.
1 secondary outcome
Oswestry Disability Index
Time frame: Enrollment, and at 6 weeks, 3 months, 6 months, 2 years, 5 years and post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
Related trials for Degenerative Spondylolisthesis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Recruiting
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Degenerative Disc Disease, Spondylolisthesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher S Bailey, MD principal investigator
The London Spine Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Interbody Fusion and Posterolateral Fusion in people with Degenerative Spondylolisthesis and Spinal Stenosis, run by The London Spine Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher S Bailey, MD (519-685-8500 ext. 55358, Chris.Bailey@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: 1 year post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.