Isthmic SpondylolisthesisNCT05701046
Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis
An observational study of Isthmic Spondylolisthesis, run by University of British Columbia at 1 site in Canada.
Trial summary
Currently there is no consensus on the best surgical treatment of patients with symptomatic isthmic spondylolisthesis (IS). Clinical equipoise exists amongst experienced clinicians on the various surgical techniques available. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Isthmic Spondylolisthesis
- What is being tested?
- Interbody fusion surgery
- Type of treatment
- Surgery or procedure
- How many people
- 489 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jan 2023to 15 Feb 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with lumbar isthmic spondylolisthesis requiring surgical treatment
Who may be able to join
- Male or female aged 18 years or older (or who have reached the age of majority in the participating province)
- Require surgical treatment for a diagnosis of single-level lumbar isthmic spondylolisthesis, any grade, in the lumbar and lumbosacral spine.
- Are able to communicate in English or French
- Anterior interbody fusion group will be defined as having had an anterior or oblique approach with a synthetic cage insertion, interbody bone graft without cage or plate-screw construct with or without posterior rod-screw construct
- Posterior interbody fusion group will have only posterior approach procedure.
Who cannot join
- Previous spinal surgery
- Specific pathology at level above and below:
- Degenerative anterolisthesis
- Pars defect above or below index level
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V6H 1N1
Charlotte Dandurand, (604) 875-5859, charlotte.dandurand@vch.ca
About this study
Official title: Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis: Multicenter Prospective Cohort Study
Currently there is no consensus on the best surgical treatment of patients with symptomatic isthmic spondylolisthesis (IS). Clinical equipoise exists amongst experienced clinicians on the various surgical techniques available.
This study will involve multiple phases to answer specific research questions comparing anterior and posterior interbody fusion in patients with lumbar isthmic spondylolisthesis. The primary end point will be 1-year proportions of patients reaching minimal clinically important difference (MCID) in terms of leg pain measured by NRS leg. The secondary endpoints will be predetermined moderate to severe AEs, reoperations for nonunion, symptomatic adjacent segment disease, radiological alignment correction and correlation with HRQOL as well as economic analysis at 1, 2, 5 and 10 years.
- Conditions
- Isthmic Spondylolisthesis
- Being tested
- Interbody fusion surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interbody fusion surgeryProcedure or surgery
Interbody fusion surgery
| Study group | Role | What they receive |
|---|---|---|
| Anterior and oblique interbody fusion (ALIF, OLIF + Posterior fixation (open or MIS) or stand-alone) | Not described Receives: Procedure: Interbody fusion surgery | |
| Posterior interbody fusion (TLIF or PLIF) (open or MIS) | Not described Receives: Procedure: Interbody fusion surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of patients reaching MCID for NRS leg at 1 year
Proportions of patients reaching MCID for NRS leg (>=3)
Measured: at 1 year follow-up
Secondary outcomes (9)
Proportion of patients with any predefined adverse events
Measured: 3 month follow-up data
Reoperation due to nonunion at index level or adjacent segment disease
Measured: 1 year- 2 year -5 year -10 year follow-up data
Change in radiological parameters
Level, Labelle classification, Degree of translation, SVA, Lumbar lordosis, segmental lordosis, sacral and spinopelvic parameters,
Measured: 1 year- 2 year -5 year -10 year follow-up data
Correlation between improvement in radiological parameters and patient reported outcomes
Measured: 1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : Numeric pain rating scale for back pain
Measured: 1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : Oswestry disability index
Measured: 1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : EuroQoL 5 dimension (EQ5D)
Measured: 1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : 12 item short form survey (SF12)
Measured: 1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : Patient Health Questionnaire Depression Scale (PHQ-8)
Measured: 1 year- 2 year -5 year -10 year follow-up data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start5 Jan 2023
- Primary completion15 Feb 2028 (estimated)
- Study completion15 Feb 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isthmic SpondylolisthesisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 489 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Dandurand, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701046
- Sponsor's protocol ID
- H22-00699
- Status last verified
- May 2024
- First submitted
- 3 Jan 2023
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis: Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05701046
- Acronym / sponsor ID
- H22-00699
- Conditions
- Isthmic Spondylolisthesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 489 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 15 Feb 2028 (estimated)
- Study completion
- 15 Feb 2038 (estimated)
- First posted
- 27 Jan 2023 (actual)
- 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.
Currently there is no consensus on the best surgical treatment of patients with symptomatic isthmic spondylolisthesis (IS). Clinical equipoise exists amongst experienced clinicians on the various surgical techniques available.
This study will involve multiple phases to answer specific research questions comparing anterior and posterior interbody fusion in patients with lumbar isthmic spondylolisthesis. The primary end point will be 1-year proportions of patients reaching minimal clinically important difference (MCID) in terms of leg pain measured by NRS leg. The secondary endpoints will be predetermined moderate to severe AEs, reoperations for nonunion, symptomatic adjacent segment disease, radiological alignment correction and correlation with HRQOL as well as economic analysis at 1, 2, 5 and 10 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior and oblique interbody fusion (ALIF, OLIF + Posterior fixation (open or MIS) or stand-alone) | – | Procedure: Interbody fusion surgery |
| Posterior interbody fusion (TLIF or PLIF) (open or MIS) | – | Procedure: Interbody fusion surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with lumbar isthmic spondylolisthesis requiring surgical treatment
Key inclusion criteria (5 listed)
- Male or female aged 18 years or older (or who have reached the age of majority in the participating province)
- Require surgical treatment for a diagnosis of single-level lumbar isthmic spondylolisthesis, any grade, in the lumbar and lumbosacral spine.
- Are able to communicate in English or French
- Anterior interbody fusion group will be defined as having had an anterior or oblique approach with a synthetic cage insertion, interbody bone graft without cage or plate-screw construct with or without posterior rod-screw construct
- Posterior interbody fusion group will have only posterior approach procedure.
Key exclusion criteria (4 listed)
- Previous spinal surgery
- Specific pathology at level above and below:
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 fusion surgeryInterbody fusion surgery | Procedure or surgery | Anterior and oblique interbody fusion (ALIF, OLIF + Posterior fixation (open or MIS) or stand-alone), Posterior interbody fusion (TLIF or PLIF) (open or MIS) |
Primary outcome
Proportions of patients reaching MCID for NRS leg at 1 year
Time frame: at 1 year follow-up
Proportions of patients reaching MCID for NRS leg (>=3)
9 secondary outcomes
Proportion of patients with any predefined adverse events
Time frame: 3 month follow-up data
Reoperation due to nonunion at index level or adjacent segment disease
Time frame: 1 year- 2 year -5 year -10 year follow-up data
Change in radiological parameters
Time frame: 1 year- 2 year -5 year -10 year follow-up data
Correlation between improvement in radiological parameters and patient reported outcomes
Time frame: 1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : Numeric pain rating scale for back pain
Time frame: 1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : Oswestry disability index
Time frame: 1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : EuroQoL 5 dimension (EQ5D)
Time frame: 1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : 12 item short form survey (SF12)
Time frame: 1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : Patient Health Questionnaire Depression Scale (PHQ-8)
Time frame: 1 year- 2 year -5 year -10 year follow-up data
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isthmic Spondylolisthesis, run by University of British Columbia 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 May 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Dandurand ((604) 875-5859, charlotte.dandurand@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions of patients reaching MCID for NRS leg at 1 year (time frame: at 1 year follow-up). 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 9 May 2024.