Isthmic Spondylolisthesis
Conditions
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.
Interventions
PROCEDUREInterbody fusion surgery
Interbody fusion surgery
Sponsors
University of British Columbia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportions of patients reaching MCID for NRS leg at 1 year | at 1 year follow-up | Proportions of patients reaching MCID for NRS leg (\>=3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | Level, Labelle classification, Degree of translation, SVA, Lumbar lordosis, segmental lordosis, sacral and spinopelvic parameters, |
| 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) : 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 | — |
| Correlation between improvement in radiological parameters and patient reported outcomes | 1 year- 2 year -5 year -10 year follow-up data | — |
Countries
Canada
Contacts
Primary ContactCharlotte Dandurand
Outcome results
None listed