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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02564705
Recruitment Status : Active, not recruiting
First Posted : October 1, 2015
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
AOSpine North America Research Network

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment
Isthmic Spondylolisthesis Procedure: Anterior Lumbar Interbody Fusion (ALIF) Procedure: Posterior Fusion

Study Design
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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Center, Prospective, Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis
Actual Study Start Date : March 2016
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
anterior cohort
Anterior Lumbar Interbody Fusion (ALIF)
 Procedure: Anterior Lumbar Interbody Fusion (ALIF)
posterior cohort
  • Posterolateral Fusion (PLF)
  • Posterior Lumbar Interbody Fusion (PLIF)
  • Transforaminal Lumbar Interbody Fusion (TLIF)
 Procedure: Posterior Fusion
  • Posterolateral Fusion (PLF)
  • Posterior Lumbar Interbody Fusion (PLIF)
  • Transforaminal Lumbar Interbody Fusion (TLIF)


Outcome Measures
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Primary Outcome Measures :
  1. Change in Oswestry Disability Index Score v2.1a [ Time Frame: between pre-operative and 730 days (24 months) ]

Secondary Outcome Measures :
  1. Change in Numeric Pain Rating Scale (Pain NRS) for low back pain [ Time Frame: between pre-operative and 730 days (24 months) ]
  2. Change in EQ-5D-3L health utility index [ Time Frame: between pre-operative and 730 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Isthmic spondylolisthesis (IS)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564705


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143-0122
United States, Illinois
Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Washington University
Saint Louis, Missouri, United States, 63110
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson University / Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Utah
University of Utah Department of Orthopedics
Salt Lake City, Utah, United States, 84108
United States, Virginia
University of Virginia Department of Neurosurgery
Charlottesville, Virginia, United States, 22908
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
AOSpine North America Research Network
More Information
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Responsible Party: AOSpine North America Research Network
ClinicalTrials.gov Identifier: NCT02564705    
Other Study ID Numbers: SPN-14-001
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Additional relevant MeSH terms:
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Spondylolisthesis
Spondylolysis
Spondylosis
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases