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Completed No phase listed Observational

Evaluation of Trinity Evolution in Patients Undergoing Foot and Ankle Fusion

ClinicalTrials.gov ID: NCT00988338

Public ClinicalTrials.gov record NCT00988338. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 10:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Radiographic and Clinical Study Evaluating a Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem Cells (Trinity Evolution Matrix) in Subjects Undergoing Foot and Ankle Fusion

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00988338
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Orthofix Inc.
Industry
Enrollment
106 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2009 (Type not available)
Primary completion
Jan 2013 (Actual)
Completion
Jan 2013 (Actual)
Last update posted
Oct 28, 2021

2009 – 2013

United States locations

U.S. sites
10
U.S. states
8
U.S. cities
10
Facility City State ZIP Site status
Orthopaedic Associates of South Broward, PA Hollywood Florida 33021 —
Sinai Hospital of Baltimore / Rubin Institute for Advanced Orthopedics Baltimore Maryland 21215 —
New Mexico Orthopedics Albuquerque New Mexico 87106 —
OrthoCarolina Research Institute Charlotte North Carolina 28203 —
Duke University Medical Center Durham North Carolina 27710 —
Ohio Orthopedic Center of Excellence Upper Arlington Ohio 43220 —
The Western Pennsylvania Hospital Pittsburgh Pennsylvania 15224 —
University Orthopedics Center State College Pennsylvania 16801 —
Central Tennessee Foot and Ankle Center Sparta Tennessee 38583 —
Franciscan Foot and Ankle Specialists Burien Washington 98166 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00988338, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 28, 2021 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00988338 live on ClinicalTrials.gov.

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