- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02564705
Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis (I-Spondy)
May 17, 2023 updated by: AOSpine North America Research Network
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
177
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
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California
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San Francisco, California, United States, 94143-0122
- University of California San Francisco
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Illinois
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Urbana, Illinois, United States, 61801
- Carle Foundation Hospital
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Kansas
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Kansas City, Kansas, United States, 66160
- Kansas University Medical Center
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University / Rothman Institute
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Utah
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Salt Lake City, Utah, United States, 84108
- University of Utah Department of Orthopedics
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia Department of Neurosurgery
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Washington
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Seattle, Washington, United States, 98122
- Swedish Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with Isthmic spondylolisthesis (IS)
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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anterior cohort
Anterior Lumbar Interbody Fusion (ALIF)
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posterior cohort
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Oswestry Disability Index Score v2.1a
Time Frame: between pre-operative and 730 days (24 months)
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between pre-operative and 730 days (24 months)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Numeric Pain Rating Scale (Pain NRS) for low back pain
Time Frame: between pre-operative and 730 days (24 months)
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between pre-operative and 730 days (24 months)
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Change in EQ-5D-3L health utility index
Time Frame: between pre-operative and 730 days
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between pre-operative and 730 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
May 5, 2023
Study Completion (Actual)
May 5, 2023
Study Registration Dates
First Submitted
September 29, 2015
First Submitted That Met QC Criteria
September 29, 2015
First Posted (Estimate)
October 1, 2015
Study Record Updates
Last Update Posted (Actual)
May 19, 2023
Last Update Submitted That Met QC Criteria
May 17, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPN-14-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Isthmic Spondylolisthesis
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University of British ColumbiaNot yet recruitingIsthmic Spondylolisthesis
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Aesculap AGRaylytic GmbH; ZKS MünsterTerminatedIsthmic Spondylolisthesis | Spine FusionGermany
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CMC Ambroise ParéCompletedIsthmic Spondylolisthesis Treated With Combined Approach: Clinical and Radiological Outcomes (SPLAC)Surgical Procedure, Unspecified | Isthmic SpondylolisthesisFrance
-
Assiut UniversityUnknown
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Peking University Third HospitalCompletedIsthmic SpondylolisthesisChina
-
Jyväskylä Central HospitalTampere University; Tampere University HospitalCompletedSpondylolisthesis, Degenerative | Spondylolisthesis, IsthmicFinland
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Seton Healthcare FamilyCelling BiosciencesWithdrawnDegenerative Disc Disease | Spinal Stenosis | Degenerative Spondylolisthesis | Isthmic-lytic SpondylolisthesisUnited States
-
Amedica CorporationCompletedDegenerative Spondylolisthesis | Disc Degeneration of Pfirrmann Grade III or Greater | Isthmic Spondylolisthesis of Grade I or IINetherlands
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Rush University Medical CenterWithdrawnDegenerative Disc Disease | Radiculopathy | Isthmic Spondylolisthesis | Degenerative Spondylolisthesis | Herniated Nucleus Pulposus | Foraminal Stenosis | Central Spinal Stenosis
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Lahey ClinicDePuy SynthesActive, not recruitingLumbar Spondylolisthesis | Lumbar Spondylosis | Degenerative SpondylolisthesisUnited States
Clinical Trials on Anterior Lumbar Interbody Fusion (ALIF)
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ExactechTerminatedDegenerative Disc Disease | Spondylolisthesis | StenosisUnited States
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University Hospital, GhentCompletedAnterior Lumbar Interbody Fusion ProcedureBelgium
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Svante BergYara AsterfjordWithdrawnDisk Degeneration | Disc Disease Degenerative | Disc Disease LumbarSweden
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Justin Parker Neurological InstituteCompletedDegenerative Disc DiseaseUnited States
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Medtronic Spinal and BiologicsTerminatedLow Back Pain | Intervertebral Disc Displacement | Spinal Stenosis | SpondylolisthesisGermany, Netherlands
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Mesoblast, Ltd.CompletedDegenerative Disc Disease | Spinal Stenosis | Degenerative SpondylolisthesisUnited States
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3SpineMCRARecruiting
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Spine and Scoliosis Research AssociatesEnrolling by invitationDegenerative Disc Disease (DDD)United States
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Aesculap AGRecruitingDisk Herniated Lumbar | Spondylolisthesis | Disc Disease DegenerativeGermany