Clinical trial NCT02564705: Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis
Official title: A Multi-Center, Prospective, Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Isthmic Spondylolisthesis
Lead sponsor: AOSpine North America Research Network
Sponsor class: NETWORK
First posted: 2015-10-01
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Isthmic spondylolisthesis (IS)

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.


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
* 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

Primary outcomes:
measure: Change in Oswestry Disability Index Score v2.1a
timeFrame: between pre-operative and 730 days (24 months)
Secondary outcomes:
measure: Change in Numeric Pain Rating Scale (Pain NRS) for low back pain
timeFrame: between pre-operative and 730 days (24 months)
measure: Change in EQ-5D-3L health utility index
timeFrame: between pre-operative and 730 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University / Rothman Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah Department of Orthopedics
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Department of Neurosurgery
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
References: