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A Pivotal Study of the Premia Spine TOPS™ System

NCT03012776 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2024-06-17

No results posted yet for this study

Summary

The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1) at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint capsule.

Success will be assessed by means of a composite endpoint that measures improvement in in patient reported outcomes and the absence of any major device related complications.

Conditions

  • Lumbar Spinal Stenosis
  • Degenerative Spondylolisthesis

Interventions

DEVICE

Total Posterior Spine System (TOPS)

Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis

PROCEDURE

Transforaminal Lumbar Interbody Fusion (TLIF)

Fusion with placement of interbody cage and posterolateral instrumentation

Sponsors & Collaborators

  • Premia Spine

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-17
Primary Completion
2022-06-27
Completion
2023-06-14
FDA Device
Yes

Countries

  • United States

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 NCT03012776 on ClinicalTrials.gov