Recruiting

Anterior vs. Posterior

Sponsor:

University of British Columbia

Code:

NCT05701046

Conditions

Isthmic Spondylolisthesis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Interbody fusion surgery

Study Details

Brief 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.

Conditions

Isthmic Spondylolisthesis

Study ID

NCT05701046

Start date

Jan 5, 2023

Status verified date

May, 2024

Completion date

Feb 15, 2038

Anticipated

Primary completion date

Feb 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

489 participants

Anticipated

Interventions and Outcome Measures

Arms

Anterior and oblique interbody fusion (ALIF, OLIF + Posterior fixation (open or MIS) or stand-alone)

Posterior interbody fusion (TLIF or PLIF) (open or MIS)

Interventions

Interbody fusion surgery

Interbody fusion surgery

Primary outcome measure

  • Proportions of patients reaching MCID for NRS leg at 1 year [ Time Frame: at 1 year follow-up ]

Central Contacts and Locations

Central contacts

Charlotte Dandurand

(604) 875-5859charlotte.dandurand@vch.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 1N1

Contacts

Charlotte Dandurand

(604) 875-5859charlotte.dandurand@vch.ca

More Information

Sponsor

University of British Columbia

Last update posted

May 9, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-05-09.