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NCT00965380 · ClinicalTrials.gov registry record

Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)

A clinical trial, sponsored by Orthofix.

Completed
Registry status
207
Enrollment target

NCT00965380 is a clinical trial that has completed, run by Orthofix. The registered enrollment target is 207 participants.

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The verdict

NCT00965380 has completed, sponsored by Orthofix.

COMPLETED
Registry status
207 participants
Enrollment target

Study Summary

The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental posterior fixation of the surgeon's choice and to follow the patients to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that Trinity Evolution combined with an interbody spacer and supplemental posterior fixation will result in fusion rates and clinical outcomes similar to those with other routinely used autograft and allograft materials including: fusion, improvement in pain and function, maintenance of lower extremity neurological function, and absence of serious adverse events related to the use of the Trinity Evolution product.

Trial Details

FieldValue
Enrollment Target 207 participants
Start Date 2009-09
Est. Completion 2015-01

Sponsor

Orthofix

14 total trials

What the Registry Record Tells You About NCT00965380

The ClinicalTrials.gov registry entry for NCT00965380 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 207 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orthofix, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00965380 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00965380 about?

NCT00965380 is a clinical study titled "Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)". The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental posterior fixation of the surgeon's choice and to follow the patients to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that Trinity Evolution combined...

What is the current status of trial NCT00965380?

This trial is currently completed. The enrollment target is 207 participants. The study started on 2009-09. Estimated completion is 2015-01.

Who is sponsoring clinical trial NCT00965380?

This trial is sponsored by Orthofix, which has 14 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.