Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis

Study Overview
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Brief Summary
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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.

Official Title
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Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis: Multicenter Prospective Cohort Study

Conditions
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Isthmic Spondylolisthesis

Intervention / Treatment
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* Procedure: Interbody fusion surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anterior and oblique interbody fusion (ALIF, OLIF + Posterior fixation (open or MIS) or stand-alone)<br> | Procedure: Interbody fusion surgery<br>* Interbody fusion surgery<br>|
| Posterior interbody fusion (TLIF or PLIF) (open or MIS)<br> | Procedure: Interbody fusion surgery<br>* Interbody fusion surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Level, Labelle classification, Degree of translation, SVA, Lumbar lordosis, segmental lordosis, sacral and spinopelvic 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 | 
| 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 | 
| 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) : Patient Health Questionnaire Depression Scale (PHQ-8) |  | 1 year- 2 year -5 year -10 year follow-up data |