Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Isthmic Spondylolisthesis
• Intervention / Treatment: Procedure: Interbody fusion surgery

• Study Type: Observational
• Enrollment (Estimated): 489

Contacts and Locations

• Study Contact: Name: Charlotte Dandurand; Phone Number: (604) 875-5859; Email: charlotte.dandurand@vch.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 1N1
      • Recruiting
      • Vancouver General Hospital
      • Contact: Charlotte Dandurand; Phone Number: (604) 875-5859; Email: charlotte.dandurand@vch.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Adult patients with lumbar isthmic spondylolisthesis requiring surgical treatment

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anterior and oblique interbody fusion (ALIF, OLIF + Posterior fixation (open or MIS) or stand-alone)	Procedure: Interbody fusion surgery; Interbody fusion surgery
Posterior interbody fusion (TLIF or PLIF) (open or MIS)	Procedure: Interbody fusion surgery; Interbody fusion surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with any predefined adverse events		3 month follow-up data
Reoperation due to nonunion at index level or adjacent segment disease		1 year- 2 year -5 year -10 year follow-up data
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
Correlation between improvement in radiological parameters and patient reported outcomes		1 year- 2 year -5 year -10 year follow-up data
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
Change in Patient's reported outcome (PRO) : Oswestry disability index		1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : EuroQoL 5 dimension (EQ5D)		1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : 12 item short form survey (SF12)		1 year- 2 year -5 year -10 year follow-up data
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

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Estimated): February 15, 2028
• Study Completion (Estimated): February 15, 2038

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: H22-00699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No