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Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws

NCT00762723 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2014-04-17

Study results available
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Summary

Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability. The system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The device's bone-plate interface is enhanced through use of fixed-angled screws,variable-angle screws or a combination of both to accommodate various combinations of screw configurations, resulting in enhanced fixation tailored to individual patient needs. Clinical outcomes data, including a comparison of different screw configurations, is needed to support the use and of the Trinica ALP System.

Conditions

  • Degenerative Disc Disease
  • Spinal Stenosis
  • Spondylolisthesis

Interventions

DEVICE

Trinica Anterior Lumbar Plate System

Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00762723 on ClinicalTrials.gov