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 Type
OBSERVATIONAL
Enrollment
489
Interbody fusion surgery
Vancouver General Hospital
Vancouver, British Columbia, Canada
RECRUITINGProportions of patients reaching MCID for NRS leg at 1 year
Proportions of patients reaching MCID for NRS leg (\>=3)
Time frame: at 1 year follow-up
Proportion of patients with any predefined adverse events
Time frame: 3 month follow-up data
Reoperation due to nonunion at index level or adjacent segment disease
Time frame: 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,
Time frame: 1 year- 2 year -5 year -10 year follow-up data
Correlation between improvement in radiological parameters and patient reported outcomes
Time frame: 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
Time frame: 1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : Oswestry disability index
Time frame: 1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : EuroQoL 5 dimension (EQ5D)
Time frame: 1 year- 2 year -5 year -10 year follow-up data
Change in Patient's reported outcome (PRO) : 12 item short form survey (SF12)
Time frame: 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)
Time frame: 1 year- 2 year -5 year -10 year follow-up data
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