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NCT00988338 · ClinicalTrials.gov registry record

Evaluation of Trinity Evolution in Patients Undergoing Foot and Ankle Fusion

A clinical trial, sponsored by Orthofix.

Completed
Registry status
106
Enrollment target

NCT00988338: Completed study, sponsored by Orthofix.

NCT00988338 is a clinical trial that has completed, run by Orthofix. The registered enrollment target is 106 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00988338 has completed, sponsored by Orthofix.

COMPLETED
Registry status
106 participants
Enrollment target

Study Summary

The purpose of this study is to utilize Trinity Evolution as a graft source in foot/ankle fusions and to follow the subjects to measure the clinical outcomes and fusion rate. The hypothesis of the study is that Trinity Evolution will result in fusion rates and clinical outcomes similar to those obtained from autograft and other routinely used allograft materials; these include: fusion, improvement in pain, improvement in function, and absence of adverse events related to the use of the graft source.

Interventions

  • BIOLOGICAL Trinity Evolution

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2009-09
Est. Completion 2013-01
Orthofix

14 total trials

What the finished NCT00988338 record still lists

NCT00988338 is an observational study that tracks outcomes without assigning an intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which Trinity Evolution is the first listed.

NCT00988338 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00988338 about?

NCT00988338 is a clinical study titled "Evaluation of Trinity Evolution in Patients Undergoing Foot and Ankle Fusion". The purpose of this study is to utilize Trinity Evolution as a graft source in foot/ankle fusions and to follow the subjects to measure the clinical outcomes and fusion rate. The hypothesis of the study is that Trinity Evolution will result in fusion rates and clinical outcomes similar to those obta...

What is the current status of trial NCT00988338?

This trial is currently completed. The enrollment target is 106 participants. The study started on 2009-09. Estimated completion is 2013-01.

What interventions are being tested in trial NCT00988338?

The interventions under investigation include: Trinity Evolution (BIOLOGICAL).

Who is sponsoring clinical trial NCT00988338?

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

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Source: ClinicalTrials.gov NCT00988338, the US trial registry maintained by the National Library of Medicine. NCT00988338 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.