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

Isthmic Spondylolisthesis Clinical Trial

— I-Spondy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564705
• Other study ID #: SPN-14-001
• Status: Completed
• Start date: March 2016
• Est. completion date: May 5, 2023

Study information

• Verified date: May 2023
• Source: AOSpine North America Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: May 5, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Isthmic Spondylolisthesis
• Spondylolisthesis

Intervention

Procedure:
• Anterior Lumbar Interbody Fusion (ALIF)

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

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Virginia Department of Neurosurgery	Charlottesville	Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Missouri	Columbia	Missouri
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Thomas Jefferson University / Rothman Institute	Philadelphia	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	University of Utah Department of Orthopedics	Salt Lake City	Utah
United States	University of California San Francisco	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	Carle Foundation Hospital	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AOSpine North America Research Network

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oswestry Disability Index Score v2.1a		between pre-operative and 730 days (24 months)
Secondary	Change in Numeric Pain Rating Scale (Pain NRS) for low back pain		between pre-operative and 730 days (24 months)
Secondary	Change in EQ-5D-3L health utility index		between pre-operative and 730 days