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NCT04299022 · ClinicalTrials.gov registry record

Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care

A clinical trial of Fractures, Bone and Fractures, Open, sponsored by LifeNet Health.

Recruiting
Registry status
250
Enrollment target
4
Study locations

NCT04299022 is a study of Fractures, Bone and Fractures, Open that is actively recruiting participants, run by LifeNet Health. The registered enrollment target is 250 participants, below the 1,925-participant average among 12 other Fractures, Bone trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT04299022, a study of Fractures, Bone and Fractures, Open, is actively recruiting participants, sponsored by LifeNet Health.

RECRUITING
Registry status
250 participants
Enrollment target
4
Study locations

Study Summary

Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.

Conditions Studied

Fractures, Bone Fractures, Open Nonunion of Fracture Fracture of Femur Fractures, Ununited Fracture, Tibial Fracture Arm

Interventions

  • OTHER Vivigen Cellular Bone Matrix

Study Locations (4)

Florida

  • OrlandoHealth - Orlando

New Jersey

  • RWJBarnabas Health - Jersey City

North Carolina

  • Duke University Medical Center - Durham

Virginia

  • Sentara Hospitals - Norfolk

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2021-06-01
Est. Completion 2026-07-31

Sponsor

LifeNet Health

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04299022

The ClinicalTrials.gov registry entry for NCT04299022 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,925-participant average among 12 other Fractures, Bone trials with a reported enrollment target (87% lower). The listed sponsor is LifeNet Health, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Fractures, Bone appearing as the primary indexed condition, and to 1 intervention - of which Vivigen Cellular Bone Matrix is the first listed.

NCT04299022 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Florida, New Jersey, North Carolina.

Frequently Asked Questions

What is clinical trial NCT04299022 about?

NCT04299022 is a clinical study titled "Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care". Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.

What is the current status of trial NCT04299022?

This trial is currently recruiting. The enrollment target is 250 participants. The study started on 2021-06-01. Estimated completion is 2026-07-31.

What conditions does trial NCT04299022 study?

This clinical trial studies the following conditions: Fractures, Bone, Fractures, Open, Nonunion of Fracture, Fracture of Femur, Fractures, Ununited.

What interventions are being tested in trial NCT04299022?

The interventions under investigation include: Vivigen Cellular Bone Matrix (OTHER).

Who is sponsoring clinical trial NCT04299022?

This trial is sponsored by LifeNet Health, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04299022 being conducted?

This trial has 4 study locations across Florida, New Jersey, North Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.