Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis

Isthmic Spondylolisthesis Clinical Trial

Official title:

Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis: Multicenter Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701046
• Other study ID #: H22-00699
• Status: Recruiting
• Start date: January 5, 2023
• Est. completion date: February 15, 2038

Study information

• Verified date: May 2024
• Source: University of British Columbia
• Contact: Charlotte Dandurand
• Phone: (604) 875-5859
• Email: charlotte.dandurand[@]vch.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Currently there is no consensus on the best surgical treatment of patients with symptomatic isthmic spondylolisthesis (IS). Clinical equipoise exists amongst experienced clinicians on the various surgical techniques available.

This study will involve multiple phases to answer specific research questions comparing anterior and posterior interbody fusion in patients with lumbar isthmic spondylolisthesis. The primary end point will be 1-year proportions of patients reaching minimal clinically important difference (MCID) in terms of leg pain measured by NRS leg. The secondary endpoints will be predetermined moderate to severe AEs, reoperations for nonunion, symptomatic adjacent segment disease, radiological alignment correction and correlation with HRQOL as well as economic analysis at 1, 2, 5 and 10 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 489
• Est. completion date: February 15, 2038
• Est. primary completion date: February 15, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female aged 18 years or older (or who have reached the age of majority in the participating province)

• Require surgical treatment for a diagnosis of single-level lumbar isthmic spondylolisthesis, any grade, in the lumbar and lumbosacral spine.

• Are able to communicate in English or French

• Anterior interbody fusion group will be defined as having had an anterior or oblique approach with a synthetic cage insertion, interbody bone graft without cage or plate-screw construct with or without posterior rod-screw construct

• Posterior interbody fusion group will have only posterior approach procedure.

Exclusion Criteria:

• Previous spinal surgery

• Specific pathology at level above and below:

• Degenerative anterolisthesis

• Pars defect above or below index level

Related Conditions & MeSH terms

• Isthmic Spondylolisthesis
• Spondylolisthesis

Intervention

Procedure:
• Interbody fusion surgery
Interbody fusion surgery

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportions of patients reaching MCID for NRS leg at 1 year	Proportions of patients reaching MCID for NRS leg (>=3)	at 1 year follow-up
Secondary	Proportion of patients with any predefined adverse events		3 month follow-up data
Secondary	Reoperation due to nonunion at index level or adjacent segment disease		1 year- 2 year -5 year -10 year follow-up data
Secondary	Change in radiological parameters	Level, Labelle classification, Degree of translation, SVA, Lumbar lordosis, segmental lordosis, sacral and spinopelvic parameters,	1 year- 2 year -5 year -10 year follow-up data
Secondary	Correlation between improvement in radiological parameters and patient reported outcomes		1 year- 2 year -5 year -10 year follow-up data
Secondary	Change in Patient's reported outcome (PRO) : Numeric pain rating scale for back pain		1 year- 2 year -5 year -10 year follow-up data
Secondary	Change in Patient's reported outcome (PRO) : Oswestry disability index		1 year- 2 year -5 year -10 year follow-up data
Secondary	Change in Patient's reported outcome (PRO) : EuroQoL 5 dimension (EQ5D)		1 year- 2 year -5 year -10 year follow-up data
Secondary	Change in Patient's reported outcome (PRO) : 12 item short form survey (SF12)		1 year- 2 year -5 year -10 year follow-up data
Secondary	Change in Patient's reported outcome (PRO) : Patient Health Questionnaire Depression Scale (PHQ-8)		1 year- 2 year -5 year -10 year follow-up data