A Multi-Center, Prospective, Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis

AOSpine North America Research Network14 sites in 2 countries177 target enrollmentMarch 2016

ConditionsIsthmic Spondylolisthesis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Isthmic Spondylolisthesis
Sponsor: AOSpine North America Research Network
Enrollment: 177
Locations: 14
Primary Endpoint: Change in Oswestry Disability Index Score v2.1a
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

May 5, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AOSpine North America Research Network

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Change in Oswestry Disability Index Score v2.1a

Time Frame: between pre-operative and 730 days (24 months)

Secondary Outcomes

Change in Numeric Pain Rating Scale (Pain NRS) for low back pain(between pre-operative and 730 days (24 months))
Change in EQ-5D-3L health utility index(between pre-operative and 730 days)