Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis (I-Spondy)

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

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

    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
    • California
      • San Francisco, California, United States, 94143-0122
        • University of California San Francisco
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University / Rothman Institute
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Department of Orthopedics
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Department of Neurosurgery
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

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
anterior cohort
Anterior Lumbar Interbody Fusion (ALIF)
posterior cohort
  • Posterolateral Fusion (PLF)
  • Posterior Lumbar Interbody Fusion (PLIF)
  • Transforaminal Lumbar Interbody Fusion (TLIF)
  • Posterolateral Fusion (PLF)
  • Posterior Lumbar Interbody Fusion (PLIF)
  • Transforaminal Lumbar Interbody Fusion (TLIF)

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)
between pre-operative and 730 days (24 months)

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)
between pre-operative and 730 days (24 months)
Change in EQ-5D-3L health utility index
Time Frame: between pre-operative and 730 days
between pre-operative and 730 days

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

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.

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