Isthmic SpondylolisthesisI-SpondyNCT02564705
Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis
An observational study of Isthmic Spondylolisthesis, run by AOSpine North America Research Network at 14 sites in 2 countries.
Trial summary
The aim of this study is to compare outcomes and cost-effectiveness of anterior versus posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry Disability Index (ODI) v2.1a and to compare… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Isthmic Spondylolisthesis
- What is being tested?
- Anterior Lumbar Interbody Fusion (ALIF) and Posterior Fusion
- Type of treatment
- Surgery or procedure
- How many people
- 177 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Mar 2016to 5 May 2023
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Isthmic spondylolisthesis (IS)
Who may be able to join
- Aged 18 to 80 years, inclusive
- Grade I, II or III (less than 75% slip of the cephalad vertebra compared to the caudal vertebra) isthmic spondylolisthesis at single level between L4 and S1
- Unresponsive to a minimum of 3 months of non-surgical treatment
- No previous surgical treatment for isthmic spondylolisthesis
- Patients who are medically suitable for surgical management
- Patients who have consented for surgical treatment
- Willing and able to comply with the Investigational Protocol (IP)
- Informed Consent Form (ICF) signed by patient
Who cannot join
- Any previous lumbar spine surgery
- Patient has significant scoliosis (Cobb angle is greater than 25 degrees)
- Subject has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction
- Subject is pregnant or of child-bearing potential and not currently on adequate birth control method
- Active infection at the surgical site
- Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the Investigator
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- Pre-existent neurologic or mental disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric disorder with hallucinations and/or delusions or schizophrenia
- Participation in another clinical trial of drug or device within the past 30 days that could influence the outcomes of this study
- Is a prisoner
- Acquired immune deficiency syndrome (AIDS) or AIDS-related complex
- Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated; patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21287
University of Virginia Department of Neurosurgery
Charlottesville, Virginia, 22908
Cleveland Clinic
Cleveland, Ohio, 44195
University of Missouri
Columbia, Missouri, 65212
Kansas University Medical Center
Kansas City, Kansas, 66160
Thomas Jefferson University / Rothman Institute
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Utah Department of Orthopedics
Salt Lake City, Utah, 84108
University of California San Francisco
San Francisco, California, 94143-0122
Swedish Medical Center
Seattle, Washington, 98122
Washington University
St Louis, Missouri, 63110
Carle Foundation Hospital
Urbana, Illinois, 61801
About this study
Official title: A Multi-Center, Prospective, Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis
The aim of this study is to compare outcomes and cost-effectiveness of anterior versus posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry Disability Index (ODI) v2.1a and to compare safety outcomes measured by treatment-related adverse events. Secondary objectives are to compare treatments in terms of differences in pain, quality of life, health utilities, and need for re-operation. Finally, a cost-effectiveness analysis will be performed. This analysis will take the form of cost-effectiveness if there is a difference in treatment effects or cost-minimization if there is no difference in treatment efficacy.
- Conditions
- Isthmic Spondylolisthesis
- Being tested
- Anterior Lumbar Interbody Fusion (ALIF), Posterior Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Lumbar Interbody Fusion (ALIF)Procedure or surgery
Posterior FusionProcedure or surgery
- Posterolateral Fusion (PLF)
- Posterior Lumbar Interbody Fusion (PLIF)
- Transforaminal Lumbar Interbody Fusion (TLIF)
| Study group | Role | What they receive |
|---|---|---|
| anterior cohort | Anterior Lumbar Interbody Fusion (ALIF) Receives: Procedure: Anterior Lumbar Interbody Fusion (ALIF) | |
| posterior cohort | * Posterolateral Fusion (PLF)
* Posterior Lumbar Interbody Fusion (PLIF)
* Transforaminal Lumbar Interbody Fusion (TLIF) Receives: Procedure: Posterior Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oswestry Disability Index Score v2.1a
Measured: between pre-operative and 730 days (24 months)
Secondary outcomes (2)
Change in Numeric Pain Rating Scale (Pain NRS) for low back pain
Measured: between pre-operative and 730 days (24 months)
Change in EQ-5D-3L health utility index
Measured: between pre-operative and 730 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startMar 2016
- Primary completion5 May 2023
- Study completion5 May 2023
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.
- 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
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- AOSpine North America Research Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564705
- Sponsor's protocol ID
- SPN-14-001
- Acronym
- I-Spondy
- Status last verified
- May 2023
- First submitted
- 29 Sep 2015
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective, Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis
- ClinicalTrials.gov ID
- NCT02564705
- Acronym / sponsor ID
- I-Spondy / SPN-14-001
- Conditions
- Isthmic Spondylolisthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- AOSpine North America Research NetworkResearch network
- Study start
- Mar 2016 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 1 Oct 2015 (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.
The aim of this study is to compare outcomes and cost-effectiveness of anterior versus posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry Disability Index (ODI) v2.1a and to compare safety outcomes measured by treatment-related adverse events. Secondary objectives are to compare treatments in terms of differences in pain, quality of life, health utilities, and need for re-operation. Finally, a cost-effectiveness analysis will be performed. This analysis will take the form of cost-effectiveness if there is a difference in treatment effects or cost-minimization if there is no difference in treatment efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anterior cohort | – | Procedure: Anterior Lumbar Interbody Fusion (ALIF)Anterior Lumbar Interbody Fusion (ALIF) |
| posterior cohort | – | Procedure: Posterior Fusion* Posterolateral Fusion (PLF) * Posterior Lumbar Interbody Fusion (PLIF) * Transforaminal Lumbar Interbody Fusion (TLIF) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Isthmic spondylolisthesis (IS)
Key inclusion criteria (8 listed)
- Aged 18 to 80 years, inclusive
- Grade I, II or III (less than 75% slip of the cephalad vertebra compared to the caudal vertebra) isthmic spondylolisthesis at single level between L4 and S1
- Unresponsive to a minimum of 3 months of non-surgical treatment
- No previous surgical treatment for isthmic spondylolisthesis
- Patients who are medically suitable for surgical management
Key exclusion criteria (11 listed)
- Any previous lumbar spine surgery
- Patient has significant scoliosis (Cobb angle is greater than 25 degrees)
- Subject has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction
- Subject is pregnant or of child-bearing potential and not currently on adequate birth control method
- Active infection at the surgical site
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 |
|---|---|---|
| Anterior Lumbar Interbody Fusion (ALIF) | Procedure or surgery | anterior cohort |
| Posterior Fusion* Posterolateral Fusion (PLF) * Posterior Lumbar Interbody Fusion (PLIF) * Transforaminal Lumbar Interbody Fusion (TLIF) | Procedure or surgery | posterior cohort |
Primary outcome
Change in Oswestry Disability Index Score v2.1a
Time frame: between pre-operative and 730 days (24 months)
2 secondary outcomes
Change in Numeric Pain Rating Scale (Pain NRS) for low back pain
Time frame: between pre-operative and 730 days (24 months)
Change in EQ-5D-3L health utility index
Time frame: between pre-operative and 730 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
Related trials for Isthmic Spondylolisthesis
RecruitingObservational study
Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis
Isthmic 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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isthmic Spondylolisthesis, run by AOSpine North America Research Network at 14 sites in 2 countries.
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 8 inclusion and 11 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: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Disability Index Score v2.1a (time frame: between pre-operative and 730 days (24 months)). 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 19 May 2023.