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

NCT02564705 | Completed

• 1 other identifier: SPN-14-001
• Study Type: observational
• Target: 177
• Locations: 2 countries
• Sites: 14

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.

Conditions

Isthmic Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• Change in Oswestry Disability Index Score v2.1a

  between pre-operative and 730 days (24 months)

Secondary Outcomes (2)

• 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

Study Arms (2)

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

Interventions

Anterior Lumbar Interbody Fusion (ALIF) PROCEDURE

anterior cohort

Posterior Fusion PROCEDURE

* Posterolateral Fusion (PLF) * Posterior Lumbar Interbody Fusion (PLIF) * Transforaminal Lumbar Interbody Fusion (TLIF)

posterior cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Isthmic spondylolisthesis (IS)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AOSpine North America Research Network: lead

Study Sites (14)

University of California San Francisco

San Francisco, California, 94143-0122, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Thomas Jefferson University / Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Utah Department of Orthopedics

Salt Lake City, Utah, 84108, United States

Location

University of Virginia Department of Neurosurgery

Charlottesville, Virginia, 22908, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 1, 2015
• Study Start: March 1, 2016
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

US (13); CA (1)