Degenerative Lumbar SpondylolisthesisNCT02290314
Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion
A study testing minimally invasive MID-line Lumbar Fusion (MIDLF) and Posterior lumbar interbody fusion (PLIF) in people with Degenerative Lumbar Spondylolisthesis, run by The London Spine Centre at 2 sites in Canada.
Trial summary
Degenerative lumbar spondylolisthesis is the forward displacement (slip) of one vertebra on an adjacent vertebra resulting in narrowing of the spinal canal or compression of the exiting nerve roots. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Lumbar Spondylolisthesis
- What is being tested?
- minimally invasive MID-line Lumbar Fusion (MIDLF) and Posterior lumbar interbody fusion (PLIF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2014to Dec 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients attending Victoria Hospital
- Degenerative spondylolisthesis in the lumbar spine at one level
- Medically Suitable for surgical management
- Able to consent for surgery
Who cannot join
- Lytic spondylolisthesis
- Non degenerative stenosis: tumor, trauma
- Active infection
- On long term disability or workers compensation claims
- Drug or alcohol misuse
- Lack of permanent home residence
Show all 12Show fewer
- Previous surgery in the lumbar spine at the surgical level
- Previous fusion in the lumbar spine
- Contraindication to surgery: medical co morbidities
- Unable to complete questionnaire: eg dementia
- Unable to give voluntary consent
- Pregnant
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
London Health Science Centre
London, Ontario, N6G 5L7
christopher S Bailey, MD, 519-685-8500 ext. 55358, chris.bailey@lhsc.on.ca
- 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: Minimal Access Midline Lumbar Fusion Versus Traditional Open Posterior Lumbar Interbody Fusion for Degenerative Lumbar Spondylolisthesis
Degenerative lumbar spondylolisthesis is the forward displacement (slip) of one vertebra on an adjacent vertebra resulting in narrowing of the spinal canal or compression of the exiting nerve roots. It is commonly associated with low back and leg pain, and is a frequent reason for spine surgery particularly in individuals over age 65 years. Recently novel minimally invasive surgical techniques have heightened public and government interest by touting benefits of reduced approached-related morbidity which in turn leads to quicker recovery, shorter hospital stay, improved short-term clinical outcomes, and reduced health care cost. However, there is no randomized controlled trial evidence to describe the actual advantages and disadvantages associated with minimally invasive spinal fusion. This pilot study is a randomized control trial comparing minimally invasive MID-line Lumbar Fusion (MIDLF) to traditional "open" posterior lumbar interbody fusion (PLIF) with respect to length of stay, approach related morbidity, patient centered outcome measures, and cost-effectiveness in the treatment of degenerative lumbar spondylolisthesis.
- Conditions
- Degenerative Lumbar Spondylolisthesis
- Being tested
- minimally invasive MID-line Lumbar Fusion (MIDLF), Posterior lumbar interbody fusion (PLIF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive MID-line Lumbar Fusion (MIDLF)Procedure or surgery
Posterior lumbar interbody fusion (PLIF)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive MID-line Lumbar Fusion (MIDLF) | Other | MIDLF surgery involves a minimally invasive midline laminectomy posterior approach to the lumbar spine. An incision that is smaller than the standard incision is made in the midline of the low back directly over the spinal levels. Afterward the pressure on the compressed nerves is released, and the disc between the affected vertebrae is completely removed. A metal cage filled with bone graft is placed as described in the PLIF procedure. Receives: Procedure: minimally invasive MID-line Lumbar Fusion (MIDLF) |
| posterior lumbar interbody fusion (PLIF) | Other | PLIF surgery involves a standard incision in the midline of the low back directly over the involved spinal levels. Afterward the pressure on the compressed nerves is released, and the disc between the affected vertebrae is completely removed. A metal cage filled with bone graft is placed in between the vertebral bodies where the disc usually lies. This will allow bone fusion (healing) to occur from one vertebral body to the other. Receives: Procedure: Posterior lumbar interbody fusion (PLIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discharge
Measured: Length of inhospital stay after surgery - average 4 days
Secondary outcomes (3)
Approach-related in-hospital morbidity
Blood loss, length of surgery, narcotic usage, nursing care, and adverse events will be compared between groups
Measured: At time of index surgery
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 commonly utilized, validated and highly reproducible.
Measured: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Cost-effectiveness of the two surgical approaches
Economic score and cost analysis for each procedure
Measured: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startDec 2014
- 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 Lumbar 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The London Spine Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christopher Bailey, The London Spine Centre
- Investigators
- Chris Bailey, Principal investigator, London Health Sciences Centre and Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290314
- Sponsor's protocol ID
- 105951
- Status last verified
- Aug 2018
- First submitted
- 7 Nov 2014
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
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
- Minimal Access Midline Lumbar Fusion Versus Traditional Open Posterior Lumbar Interbody Fusion for Degenerative Lumbar Spondylolisthesis
- ClinicalTrials.gov ID
- NCT02290314
- Acronym / sponsor ID
- 105951
- Conditions
- Degenerative Lumbar Spondylolisthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The London Spine CentreUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 14 Nov 2014 (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 lumbar spondylolisthesis is the forward displacement (slip) of one vertebra on an adjacent vertebra resulting in narrowing of the spinal canal or compression of the exiting nerve roots. It is commonly associated with low back and leg pain, and is a frequent reason for spine surgery particularly in individuals over age 65 years. Recently novel minimally invasive surgical techniques have heightened public and government interest by touting benefits of reduced approached-related morbidity which in turn leads to quicker recovery, shorter hospital stay, improved short-term clinical outcomes, and reduced health care cost. However, there is no randomized controlled trial evidence to describe the actual advantages and disadvantages associated with minimally invasive spinal fusion. This pilot study is a randomized control trial comparing minimally invasive MID-line Lumbar Fusion (MIDLF) to traditional "open" posterior lumbar interbody fusion (PLIF) with respect to length of stay, approach related morbidity, patient centered outcome measures, and cost-effectiveness in the treatment of degenerative lumbar spondylolisthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimally invasive MID-line Lumbar Fusion (MIDLF) | Other | Procedure: minimally invasive MID-line Lumbar Fusion (MIDLF)MIDLF surgery involves a minimally invasive midline laminectomy posterior approach to the lumbar spine. An incision that is smaller than the standard incision is made in the midline of the low back directly over the spinal levels. Afterward the pressure on the compressed nerves is released, and the disc between the affected vertebrae is completely removed. A metal cage filled with bone graft is placed as described in the PLIF procedure. |
| posterior lumbar interbody fusion (PLIF) | Other | Procedure: Posterior lumbar interbody fusion (PLIF)PLIF surgery involves a standard incision in the midline of the low back directly over the involved spinal levels. Afterward the pressure on the compressed nerves is released, and the disc between the affected vertebrae is completely removed. A metal cage filled with bone graft is placed in between the vertebral bodies where the disc usually lies. This will allow bone fusion (healing) to occur from one vertebral body to the other. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients attending Victoria Hospital
- Degenerative spondylolisthesis in the lumbar spine at one level
- Medically Suitable for surgical management
- Able to consent for surgery
Key exclusion criteria (12 listed)
- Lytic spondylolisthesis
- Non degenerative stenosis: tumor, trauma
- Active infection
- On long term disability or workers compensation claims
- Drug or alcohol misuse
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 |
|---|---|---|
| minimally invasive MID-line Lumbar Fusion (MIDLF) | Procedure or surgery | minimally invasive MID-line Lumbar Fusion (MIDLF) |
| Posterior lumbar interbody fusion (PLIF) | Procedure or surgery | posterior lumbar interbody fusion (PLIF) |
Primary outcome
Time to discharge
Time frame: Length of inhospital stay after surgery - average 4 days
3 secondary outcomes
Approach-related in-hospital morbidity
Time frame: At time of index surgery
Oswestry Disability Index
Time frame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Cost-effectiveness of the two surgical approaches
Time frame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
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.
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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.
Chris Bailey principal investigator
London Health Sciences Centre and Western University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive MID-line Lumbar Fusion (MIDLF) and Posterior lumbar interbody fusion (PLIF) in people with Degenerative Lumbar Spondylolisthesis, run by The London Spine Centre at 2 sites 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 4 inclusion and 12 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 2 sites 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.
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 Jennifer Urquhart (5196858500 ext. 53062, jennifer.urquhart@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to discharge (time frame: Length of inhospital stay after surgery - average 4 days). 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.