Clinical trial NCT05701046: Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis
Official title: Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis: Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Isthmic Spondylolisthesis
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with lumbar isthmic spondylolisthesis requiring surgical treatment

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportions of patients reaching MCID for NRS leg at 1 year
timeFrame: at 1 year follow-up
Secondary outcomes:
measure: Proportion of patients with any predefined adverse events
timeFrame: 3 month follow-up data
measure: Reoperation due to nonunion at index level or adjacent segment disease
timeFrame: 1 year- 2 year -5 year -10 year follow-up data
measure: Change in radiological parameters
timeFrame: 1 year- 2 year -5 year -10 year follow-up data
measure: Correlation between improvement in radiological parameters and patient reported outcomes
timeFrame: 1 year- 2 year -5 year -10 year follow-up data
measure: Change in Patient's reported outcome (PRO) : Numeric pain rating scale for back pain
timeFrame: 1 year- 2 year -5 year -10 year follow-up data
measure: Change in Patient's reported outcome (PRO) : Oswestry disability index
timeFrame: 1 year- 2 year -5 year -10 year follow-up data
measure: Change in Patient's reported outcome (PRO) : EuroQoL 5 dimension (EQ5D)
timeFrame: 1 year- 2 year -5 year -10 year follow-up data
measure: Change in Patient's reported outcome (PRO) : 12 item short form survey (SF12)
timeFrame: 1 year- 2 year -5 year -10 year follow-up data
measure: Change in Patient's reported outcome (PRO) : Patient Health Questionnaire Depression Scale (PHQ-8)
timeFrame: 1 year- 2 year -5 year -10 year follow-up data
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
References: