CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Sagittal plane shear index (SPSI)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03754972
NCT03754972N/ACompleted
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The Sagittal Plane Shear Index (SPSI) for Planning Whether to Fuse After Decompressing a Stenotic Lumbar Level

Medical Metrics Diagnostics, Inc·interventional·Posted Nov 27, 2018·Updated May 29, 2025

In Brief

A clinical study evaluating Sagittal plane shear index (SPSI) for Lumbar Spinal Stenosis and Spondylolisthesis. Completed, enrolled 100 participants across 3 sites.

Detailed Summary

The objective of the clinical investigation is to assess the proportion of lumbar spinal stenosis surgical treatment plans that change when an objective measurement of spinal stability is included and applied following a simple treatment algorithm. The objective spinal stability metric is calculated from flexion-extension radiographs using previously validated methods.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLumbar Spinal Stenosis, Spondylolisthesis
CountriesNetherlands
CollaboratorsAvania

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 27, 2018
Enrollment StartFeb 20, 2019
Primary CompletionSep 1, 2023
Study CompletionMar 1, 2025
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.6 years ago

Interventions

Sagittal plane shear index (SPSI)other

Report SPSI to surgeon after surgeon records an initial surgical plan, and determine whether the objective spinal stability metric influences a change in the surgical plan.