NCT05701046

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
489

participants targeted

Target at P75+ for all trials

Timeline
143mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jan 2023Feb 2038

First Submitted

Initial submission to the registry

January 3, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

January 5, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2028

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2038

Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

5.1 years

First QC Date

January 3, 2023

Last Update Submit

May 7, 2024

Conditions

Isthmic Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

    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

  • +4 more secondary outcomes

Study Arms (2)

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

Procedure: Interbody fusion surgery

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

Procedure: Interbody fusion surgery

Interventions

Interbody fusion surgeryPROCEDURE

Interbody fusion surgery

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with lumbar isthmic spondylolisthesis requiring surgical treatment

You may qualify if:

  • 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.

You may not qualify if:

  • Previous spinal surgery
  • Specific pathology at level above and below:
  • Degenerative anterolisthesis
  • Pars defect above or below index level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V6H 1N1, Canada

RECRUITING

Central Study Contacts

Charlotte Dandurand

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Spinal Neurosurgeon

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 27, 2023

Study Start

January 5, 2023

Primary Completion (Estimated)

February 15, 2028

Study Completion (Estimated)

February 15, 2038

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations

CA(1)