Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 80
Updated:1/17/2019
Start Date:March 2016
End Date:April 2021
Contact:Paul Arnold, MD
Email:parnold@kumc.edu
Phone:(913) 588-7587

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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.


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
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Saint Louis, Missouri 63110
Principal Investigator: Wilson Zack Ray, MD
Phone: 314-362-9959
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Daniel Sciubba, MD
Phone: 410-955-4424
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9500 Euclid Avenue
Cleveland, Ohio 44106
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Principal Investigator: Thomaz Mroz
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22 S Greene St
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Principal Investigator: Steven Ludwig, MD
Phone: 410-328-8808
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Charlottesville, Virginia 22908
Principal Investigator: Christopher Shaffrey, MD
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Columbia, Missouri 65211
(573) 882-2121
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Kansas City, Kansas
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: James Harrop, MD
Phone: 215-955-7000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, Pennsylvania 19107
Principal Investigator: Alexander Vaccaro, MD, PhD
Phone: 267-339-3578
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590 Wakara Way
Salt Lake City, Utah 84108
Principal Investigator: Darrel Brodke, MD
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San Francisco, California 94143
Phone: 415-353-2348
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
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Phone: 206-731-3466
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Toronto, Ontario
Principal Investigator: Michael Fehlings, MD, PhD
Phone: (416) 603-5627
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