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Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery

NCT03754972 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-29

Study results available
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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.

Conditions

  • Lumbar Spinal Stenosis
  • Spondylolisthesis

Interventions

DIAGNOSTIC_TEST

Sagittal plane shear index (SPSI)

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.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Medical Metrics Diagnostics, Inc

    lead INDUSTRY

Principal Investigators

  • John Hipp, PhD · Medical Metrics Diagnostics, Inc

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2023-09-01
Completion
2025-03-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03754972 on ClinicalTrials.gov