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.

Eligibility Criteria

Inclusion Criteria:

- Aged 18 to 55 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

Principal Investigator

Paul Arnold, MD, parnold@kumc.edu, (913) 588-7587

Study Contact

Linda Jianas

Estimated Completion Date

Wednesday, May 1, 2019

ClinicalTrials.gov #

NCT02564705
02/11/2016