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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior and oblique interbody fusion (ALIF, OLIF + Posterior fixation (open or MIS) or stand-alone) |
| ||
| Posterior interbody fusion (TLIF or PLIF) (open or MIS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interbody fusion surgery | Procedure | Interbody fusion surgery |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Previous spinal surgery
Specific pathology at level above and below:
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Adult patients with lumbar isthmic spondylolisthesis requiring surgical treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte Dandurand | Contact | (604) 875-5859 | charlotte.dandurand@vch.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V6H 1N1 | Canada |
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| 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 |