Trials / Completed
CompletedNCT02564705
Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis
A Multi-Center, Prospective, Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 177 (actual)
- Sponsor
- AOSpine North America Research Network · Network
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to compare outcomes and cost-effectiveness of anterior versus posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry Disability Index (ODI) v2.1a and to compare safety outcomes measured by treatment-related adverse events. Secondary objectives are to compare treatments in terms of differences in pain, quality of life, health utilities, and need for re-operation. Finally, a cost-effectiveness analysis will be performed. This analysis will take the form of cost-effectiveness if there is a difference in treatment effects or cost-minimization if there is no difference in treatment efficacy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Anterior Lumbar Interbody Fusion (ALIF) | |
| PROCEDURE | Posterior Fusion | * Posterolateral Fusion (PLF) * Posterior Lumbar Interbody Fusion (PLIF) * Transforaminal Lumbar Interbody Fusion (TLIF) |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2023-05-05
- Completion
- 2023-05-05
- First posted
- 2015-10-01
- Last updated
- 2023-05-19
Locations
14 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02564705. Inclusion in this directory is not an endorsement.